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101 rows where docket_id = "FDA-2015-N-5017" and posted_year = 2016 sorted by posted_date descending

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  • 2016 · 101 ✖

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id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2015-N-5017-0175 FDA None FDA-2015-N-5017 Reference 1 (FR)- Guidance for Industry and FDA Staff Medical Glove Guidance Manual, January 22, 2008 re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:29:38Z   0 0 09000064824268cf
FDA-2015-N-5017-0185 FDA None FDA-2015-N-5017 Reference 13 (FR) - Zarra, T. Lambrianidis, Skin Reactions amongst Greek endodontists Int Endod J._2015 re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:30:30Z   0 0 09000064824269c9
FDA-2015-N-5017-0189 FDA None FDA-2015-N-5017 Reference 17 (FR) - Global Industry Analysts, Inc., Disposable Medical Gloves A Global Strategic Business Report, 2008 re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:30:44Z   0 0 09000064824269cd
FDA-2015-N-5017-0184 FDA None FDA-2015-N-5017 Reference 10 (FR) - Sawyer, J. and A. Bennett, Comparing the Level of Dexterity Offered by Latex and Nitrile SafeSkin Gloves, re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:30:27Z   0 0 09000064824268d8
FDA-2015-N-5017-0187 FDA None FDA-2015-N-5017 Reference 15 (FR) - Benesfa-Colas et al., 2015 Occupational contact urticaria BJD re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:30:37Z   0 0 09000064824269cb
FDA-2015-N-5017-0192 FDA None FDA-2015-N-5017 Reference 20 (FR) - Allmers, H., J. Schmengler, and C. Skudlik, Primary Prevention of Natural Rubber Latex Allergy in the Ger re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:30:54Z   0 0 09000064824269d0
FDA-2015-N-5017-0176 FDA None FDA-2015-N-5017 References 2, 11 &12 (FR) - ASTM Standards re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:29:41Z   0 0 09000064824268d0
FDA-2015-N-5017-0177 FDA None FDA-2015-N-5017 Reference 3 (FR)- Cote, S.J., M.D. Fisher, J.N. Kheir, et al., Ease of Donning Commercially Available Latex Examination Glo re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:29:44Z   0 0 09000064824268d1
FDA-2015-N-5017-0173 FDA None FDA-2015-N-5017 Banned Devices; Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Rule Final Rule 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:09:59Z 2016-30382 0 0 0900006482423312
FDA-2015-N-5017-0196 FDA None FDA-2015-N-5017 Reference 24 (FR), FDA EA_and_FONSI Document (Glove Powder Ban Final Rule) re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:31:08Z   0 0 09000064824268e9
FDA-2015-N-5017-0186 FDA None FDA-2015-N-5017 Reference 14 (FR) - Aghaee et al., Comparison of Powdered and powder-free surgical gloves on adhesions in rats_2013 re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:30:34Z   0 0 09000064824269ca
FDA-2015-N-5017-0190 FDA None FDA-2015-N-5017 Reference 18 (FR) - Saary, M.J., A. Kanani, H. Alghadeer, et al., Changes in Rates of Natural Rubber Latex Sensitivity Among re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:30:47Z   0 0 09000064824269ce
FDA-2015-N-5017-0191 FDA None FDA-2015-N-5017 Reference 19 (FR) - Tarlo, S.M., A. Easty, K. Eubanks, et al., Outcomes of a Natural Rubber Latex Control Program in an Ontar re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:30:50Z   0 0 09000064824269cf
FDA-2015-N-5017-0194 FDA None FDA-2015-N-5017 Reference 22 (FR) - Dave, J., M.H. Wilcox, and M. Kellett, Glove Powder Implications for Infection Control, Journal of Hospit Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:31:01Z   0 0 09000064824269d2
FDA-2015-N-5017-0174 FDA None FDA-2015-N-5017 List of References- Powdered Glove Ban Final Rule re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:29:34Z   0 0 09000064824264f8
FDA-2015-N-5017-0195 FDA None FDA-2015-N-5017 Reference 23 (FR) - FDA Final Regulatory Impact Analysis, Powdered Glove Ban Final Rule re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:31:04Z   0 0 09000064824268e8
FDA-2015-N-5017-0178 FDA None FDA-2015-N-5017 Reference 4 (FR)- Korniewicz, D.M., M.M. El-Masri, J.M. Broyles, et al., A laboratory based study to assess the performance of surgical gloves re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:29:47Z   0 0 09000064824268d2
FDA-2015-N-5017-0188 FDA None FDA-2015-N-5017 Reference 16 (FR)- Palosuo T et al., Latex Medical Gloves Time for a Reappraisal 2011 re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:30:40Z   0 0 09000064824269cc
FDA-2015-N-5017-0180 FDA None FDA-2015-N-5017 Reference 6 (FR) - Fisher, M.D., V.R. Reddy, F.M. Williams, et al., Biomechanical Performance of Powder-Free Examination Glov re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:29:54Z   0 0 09000064824268d4
FDA-2015-N-5017-0183 FDA None FDA-2015-N-5017 Reference 9 (FR) - Rego, A. and L. Roley, In-Use Barrier Integrity of Gloves Latex and Nitrile Superior to Vinyl, American J re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:30:24Z   0 0 09000064824268d7
FDA-2015-N-5017-0193 FDA None FDA-2015-N-5017 Reference 21 (FR) - Charous, B.L., P.J. Schuenemann, and M.C. Swanson, Passive Dispersion of Latex Aeroallergen in a Healthca re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:30:58Z   0 0 09000064824269d1
FDA-2015-N-5017-0179 FDA None FDA-2015-N-5017 Reference 5 (FR) - Kerr, L.N., M.P. Chaput, L.D. Cash, et al., Assessment of the Durability of Medical Examination Gloves, J re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:29:50Z   0 0 09000064824268d3
FDA-2015-N-5017-0181 FDA None FDA-2015-N-5017 Reference 7 (FR) - Korniewicz, D.M., M. El-Masri, J.M. Broyles, et al., Performance of Latex and Nonlatex Medical Examinatio re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:30:18Z   0 0 09000064824268d5
FDA-2015-N-5017-0182 FDA None FDA-2015-N-5017 Reference 8 (FR)- Patel, H.B., G.J. Fleming, and F.J. Burke, Puncture Resistance and Stiffness of Nitrile and Latex Dental re Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-12-19T05:00:00Z 2016 12     2016-12-19T16:30:21Z   0 0 09000064824268d6
FDA-2015-N-5017-0055 FDA None FDA-2015-N-5017 Reference 54 - Gnaneswaran, V., B. Mudhunuri, , and R.R. Bishu, A Study of Latex and Vinyl Gloves Performance Versus Allergy Protection Properties re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:00:28Z   0 0 0900006481ed7512
FDA-2015-N-5017-0051 FDA None FDA-2015-N-5017 Reference 50 - Mecke, H., K. Semm, I. Freys, et al., Incidence of Adhesions in the True Pelvis After Pelviscopic Operative Treatment of Tubal Pregnancy re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T14:50:46Z   0 0 0900006481ed73bd
FDA-2015-N-5017-0054 FDA None FDA-2015-N-5017 Reference 53 - Cote, S.J., M.D. Fisher, J.N. Kheir, et al., Ease of Donning Commercially Available Latex Examination Gloves re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T14:57:30Z   0 0 0900006481ed73c3
FDA-2015-N-5017-0064 FDA None FDA-2015-N-5017 Reference 64 - Edlich, R.F., C.R. Woodard, S.A. Pine, et al., Hazards of Powder on Surgical and Examination Gloves: A Collective Review re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:35:15Z   0 0 0900006481ed73d7
FDA-2015-N-5017-0065 FDA None FDA-2015-N-5017 Reference 65 - Medical Devices Agency, Medical Devices Agency Safety Notice 9825 Latex Medical Gloves (Surgeons’ and Examination) re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:37:57Z   0 0 0900006481ed73d8
FDA-2015-N-5017-0046 FDA None FDA-2015-N-5017 Reference 45 - Aarons, J. and N. Fitzgerald, The Persisting Hazards of Surgical Glove Powder, Surgery, Gynecology, and Obstetrics, 138(3)385-390, 1974 re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T14:36:32Z   0 0 0900006481ed7507
FDA-2015-N-5017-0057 FDA None FDA-2015-N-5017 Reference 56 - Handfield-Jones, S.E., Latex Allergy in Health-Care Workers in an English District General Hospital re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:05:51Z   0 0 0900006481ed7514
FDA-2015-N-5017-0068 FDA None FDA-2015-N-5017 Reference 68 - Bolyard, E.A., O.C. Tablan, W.W. Williams, et al., Guideline for Infection Control in Healthcare Personnel, 1998 re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:45:37Z   0 0 0900006481ed73dc
FDA-2015-N-5017-0048 FDA None FDA-2015-N-5017 Reference 47 - Sharefkin, J.B., K.D. Fairchild, R.A. Albus, et al., The Cytotoxic Effect of Surgical Glove Powder Particles on Adult Human Vascular Endothelial Cell Cultures: Implications for Clinical Uses of Tissue Culture Techniques re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T14:43:14Z   0 0 0900006481ed750a
FDA-2015-N-5017-0058 FDA None FDA-2015-N-5017 Reference 57 - Sellar, P.W. and R.A. Sparrow, Are Ophthalmic Surgeons Aware That Starch Powdered Surgical Gloves Are a Risk Factor in Ocular Surgery re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:08:20Z   0 0 0900006481ed7515
FDA-2015-N-5017-0052 FDA None FDA-2015-N-5017 Reference 51 - Ylikorkala, O., Tubal Ligation Reduces the Risk of Ovarian Cancer re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T14:53:02Z   0 0 0900006481ed73c1
FDA-2015-N-5017-0067 FDA None FDA-2015-N-5017 Reference 67 - U.S. Department of Labor, OSHA, Potential for Sensitization and Possible Allergic Reaction To Natural Rubber Latex Gloves and other Natural Rubber Products re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:42:41Z   0 0 0900006481ed73db
FDA-2015-N-5017-0073 FDA None FDA-2015-N-5017 Reference 73 - Korniewicz, D.M., N. Chookaew, M. El-Masri, et al., Impact of Converting to Powder-Free Gloves Decreasing the Symptoms of Latex Exposure in Operating Room Personnel re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T16:00:19Z   0 0 0900006481ed73f0
FDA-2015-N-5017-0045 FDA None FDA-2015-N-5017 Reference 44 - Suding, P., T. Nguyen, I. Gordon, et al., Glove Powder Increases Staphylococcus Aureus Abscess Rate in a Rat Model re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T14:33:33Z   0 0 0900006481ed7506
FDA-2015-N-5017-0044 FDA None FDA-2015-N-5017 Reference 42 - Dave, J., M.H. Wilcox, and M. Kellett, Glove Powder Implications for Infection Control, Journal of Hospital Infection re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T14:28:24Z   0 0 0900006481ed7504
FDA-2015-N-5017-0056 FDA None FDA-2015-N-5017 Reference 55 - Tarlo, S.M., A. Easty, K. Eubanks, et al., Outcomes of a Natural Rubber Latex Control Program in an Ontario Teaching Hospital re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:03:11Z   0 0 0900006481ed7513
FDA-2015-N-5017-0061 FDA None FDA-2015-N-5017 Reference 60 - American College of Allergy, Asthma and Immunology, AAAAI and ACAAI Joint Statement Concerning the Use of Powdered and Non-Powdered Natural Rubber Latex Gloves re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:21:01Z   0 0 0900006481ed7518
FDA-2015-N-5017-0077 FDA None FDA-2015-N-5017 Reference 61 - American Nurses Association, American Nurses Association Fact Sheet, May 2011 re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T16:05:41Z   0 0 0900006481ed751a
FDA-2015-N-5017-0075 FDA None FDA-2015-N-5017 Reference 75 - Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for Banned Devices Proposal to Ban re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T16:04:17Z   0 0 0900006481ed73f2
FDA-2015-N-5017-0049 FDA None FDA-2015-N-5017 Reference 48 - Liakakos, T., N. Thomakos, P.M. Fine, et al., Peritoneal Adhesions Etiology, Pathophysiology, and Clinical Significance re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T14:45:29Z   0 0 0900006481ed73ba
FDA-2015-N-5017-0069 FDA None FDA-2015-N-5017 Reference 69 - Blumenstock, J.S., E. Bresnitz, and K. O'Leary, Guidelines Management of Natural Rubber Latex Allergy re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:47:37Z   0 0 0900006481ed73dd
FDA-2015-N-5017-0074 FDA None FDA-2015-N-5017 Reference 74 - Ranta, P.M. and D.R. Ownby, A Review of Natural-Rubber Latex Allergy in Health Care Workers re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T16:02:11Z   0 0 0900006481ed73f1
FDA-2015-N-5017-0060 FDA None FDA-2015-N-5017 Reference 59 - CDC, Preventing Allergic Reactions to Natural Rubber Latex in the Workplace, NIOSH Alert re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:17:05Z   0 0 0900006481ed7517
FDA-2015-N-5017-0062 FDA None FDA-2015-N-5017 Reference 62 - Meyer, K.K. and D.H. Beezhold, Latex Allergy How Safe Are Your Gloves re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:26:14Z   0 0 0900006481ed751b
FDA-2015-N-5017-0071 FDA None FDA-2015-N-5017 Reference 71 - Olmsted, R., APIC response to FDA Docket # FDA-2011-N-0027, available at www.regulations.gov, 2011 re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:53:02Z   0 0 0900006481ed73df
FDA-2015-N-5017-0053 FDA None FDA-2015-N-5017 Reference 52 - Global Industry Analysts, Inc., Disposable Medical Gloves A Global Strategic Business Report, 2008 re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T14:55:12Z   0 0 0900006481ed73c2
FDA-2015-N-5017-0076 FDA None FDA-2015-N-5017 Reference 43 - Odum, B.C., J.S. O'Keefe, W. Lara, et al., Influence of Absorbable Dusting Powders on Wound Infection re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T16:05:14Z   0 0 0900006481ed7505
FDA-2015-N-5017-0063 FDA None FDA-2015-N-5017 Reference 63 - Edlich, R.F., W.B. Long, D.K. Gubler, et al., Dangers of Cornstarch Powder on Medical Gloves Seeking a Solution re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:28:41Z   0 0 0900006481ed73d6
FDA-2015-N-5017-0070 FDA None FDA-2015-N-5017 Reference 70 - United Kingdom National Health Service, N.P., Royal College of Physicians, Latex Allergy Occupational Aspects of Management re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:50:47Z   0 0 0900006481ed73de
FDA-2015-N-5017-0047 FDA None FDA-2015-N-5017 Reference 46 - Hamlin, C.R., A.L. Black, and J.T. Opalek, Assay Interference Caused by Powder From Prepowdered Latex Gloves re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T14:39:33Z   0 0 0900006481ed7509
FDA-2015-N-5017-0050 FDA None FDA-2015-N-5017 Reference 49 - Mahadevan, M.M., D. Wiseman, A. Leader, et al., The Effects of Ovarian Adhesive Disease Upon Follicular Development in Cycles of Controlled Stimulation for In Vitro Fertilization re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T14:48:13Z   0 0 0900006481ed73bc
FDA-2015-N-5017-0043 FDA None FDA-2015-N-5017 Reference 41 - Smither, A.R., A.L. Winthrop, and H.G. Mesrobian, Bilateral Scrotal Masses in an Infant Remote Presentation of an Inflammatory Reaction to Surgical Glove Powder re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T14:17:23Z   0 0 0900006481ed7503
FDA-2015-N-5017-0059 FDA None FDA-2015-N-5017 Reference 58 - Petsonk, E.L., Couriers of Asthma Antigenic Proteins in Natural Rubber Latex re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:12:02Z   0 0 0900006481ed7516
FDA-2015-N-5017-0066 FDA None FDA-2015-N-5017 Reference 66 - Latza, U., F. Haamann, and X. Baur, Effectiveness of a Nationwide Interdisciplinary Preventive Programme for Latex Allergy re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:40:11Z   0 0 0900006481ed73da
FDA-2015-N-5017-0072 FDA None FDA-2015-N-5017 Reference 72 - Finding of No Significant Impact (FONSI) and Environmental Assessment (EA) for Proposed Rule to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-24T15:57:49Z   0 0 0900006481ed73ef
FDA-2015-N-5017-0010 FDA None FDA-2015-N-5017 Reference 8 - Ahmed, S.M., T.C. Aw, and A. Adisesh, Toxicological and Immunological Aspects of Occupational Latex Allergy re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T18:39:34Z   0 0 0900006481ed7374
FDA-2015-N-5017-0011 FDA None FDA-2015-N-5017 Reference 9 - Fisher, M.D., V.R. Reddy, F.M. Williams, et al., Biomechanical Performance of Powder-Free Examination Gloves re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T18:43:13Z   0 0 0900006481ed7375
FDA-2015-N-5017-0009 FDA None FDA-2015-N-5017 Reference 7 - Draft Guidance for Industry and FDA Recommended Warning for Surgeons Gloves and Patient Exam Gloves, issued February 7, 2011 withdrawn 2015 re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T18:37:05Z   0 0 0900006481ed7373
FDA-2015-N-5017-0014 FDA None FDA-2015-N-5017 Reference 12 - Patel, H.B., G.J. Fleming, and F.J. Burke, Puncture Resistance and Stiffness of Nitrile and Latex Dental Examination Gloves re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T18:58:58Z   0 0 0900006481ed737a
FDA-2015-N-5017-0002 FDA None FDA-2015-N-5017 List of References re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T18:22:31Z   0 0 0900006481ed7098
FDA-2015-N-5017-0024 FDA None FDA-2015-N-5017 Reference 22 - Kujala, V., H. Alenius, T. Palosuo, et al., Extractable Latex Allergens in Airborne Glove Powder and in Cut Glove Pieces re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:19:46Z   0 0 0900006481ed70ef
FDA-2015-N-5017-0026 FDA None FDA-2015-N-5017 Reference 24 - Barbara, J., M.C. Santais, D.A. Levy, et al., Immunoadjuvant Properties of Glove Cornstarch Powder in Latex-Induced Hypersensitivity re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:28:40Z   0 0 0900006481ed70f1
FDA-2015-N-5017-0029 FDA None FDA-2015-N-5017 Reference 27 - Allmers, H., J. Schmengler, and C. Skudlik, Primary Prevention of Natural Rubber Latex Allergy in the German Health Care System Through Education and Intervention re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:37:05Z   0 0 0900006481ed70f6
FDA-2015-N-5017-0036 FDA None FDA-2015-N-5017 Reference 34 - Malerich, P.G., M.L. Wilson, and C.M. Mowad, The Effect of a Transition to Powder-Free Latex Gloves on Workers' Compensation Claims for Latex-Related Illness re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T20:49:19Z   0 0 0900006481ed739e
FDA-2015-N-5017-0020 FDA None FDA-2015-N-5017 Reference 18 - Luijendijk, R.W., D.C. de Lange, C.C. Wauters, et al., Foreign Material in Postoperative Adhesions, Annals of Surgery re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:13:26Z   0 0 0900006481ed70e2
FDA-2015-N-5017-0004 FDA None FDA-2015-N-5017 Reference 2 ASTM D6124-11 Standard Test Method for Residual Powder on Medical Gloves re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T18:27:48Z   0 0 0900006481ed709a
FDA-2015-N-5017-0025 FDA None FDA-2015-N-5017 Reference 23 - Saary, M.J., A. Kanani, H. Alghadeer, et al., Changes in Rates of Natural Rubber Latex Sensitivity Among Dental School Students and Staff Members After Changes in Latex Gloves re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:26:25Z   0 0 0900006481ed70f0
FDA-2015-N-5017-0032 FDA None FDA-2015-N-5017 Reference 30 - Filon, F.L. and G. Radman, Latex Allergy A Follow Up Study of 1040 Healthcare Workers re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:42:32Z   0 0 0900006481ed7399
FDA-2015-N-5017-0037 FDA None FDA-2015-N-5017 Reference 35 - Vandenplas, O., A. Larbanois, F. Vanassche, et al., Latex-Induced Occupational Asthma Time Trend in Incidence and Relationship With Hospital Glove Policies re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T20:51:18Z   0 0 0900006481ed739f
FDA-2015-N-5017-0041 FDA None FDA-2015-N-5017 Reference 39 - van den Tol, M.P., R. Haverlag, M.E. van Rossen, et al., Glove Powder Promotes Adhesion Formation and Facilitates Tumour Cell Adhesion and Growth re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T21:00:35Z   0 0 0900006481ed7501
FDA-2015-N-5017-0003 FDA None FDA-2015-N-5017 Reference 1 - Guidance for Industry and FDA Staff Medical Glove Guidance Manual, January 22, 2008 re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T18:26:29Z   0 0 0900006481ed7099
FDA-2015-N-5017-0005 FDA None FDA-2015-N-5017 Reference 3 - Ellis, H., The Hazards of Surgical Glove Dusting Powders, Surgery, Gynecology and Obstetrics, 171(6)521-52 re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T18:30:47Z   0 0 0900006481ed709b
FDA-2015-N-5017-0023 FDA None FDA-2015-N-5017 Reference 21 - Edelstam, G., L. Arvanius, and G. Karlsson, Glove Powder in the Hospital Environment--Consequences for Healthcare Workers re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:18:07Z   0 0 0900006481ed70e7
FDA-2015-N-5017-0018 FDA None FDA-2015-N-5017 Reference 16 - Truscott, W., The Industry Perspective on Latex, Immunology and Allergy Clinics of North America, 15(1)89 re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:04:51Z   0 0 0900006481ed70e0
FDA-2015-N-5017-0022 FDA None FDA-2015-N-5017 Reference 20 - Charous, B.L., P.J. Schuenemann, and M.C. Swanson, Passive Dispersion of Latex Aeroallergen in a Healthcare Facility re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:16:46Z   0 0 0900006481ed70e4
FDA-2015-N-5017-0021 FDA None FDA-2015-N-5017 Reference 19 - McEntee, G.P., R.C. Stuart, P.J. Byrne, et al., Experimental Study of Starch-Induced Intraperitoneal Adhesions re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:14:55Z   0 0 0900006481ed70e3
FDA-2015-N-5017-0015 FDA None FDA-2015-N-5017 Reference 13 - Rego, A. and L. Roley, In-Use Barrier Integrity of Gloves Latex and Nitrile Superior to Vinyl re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:00:31Z   0 0 0900006481ed737b
FDA-2015-N-5017-0001 FDA None FDA-2015-N-5017 Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Proposed Rule Notice of Proposed Rulemaking (NPRM) 2016-03-22T04:00:00Z 2016 3 2016-03-22T04:00:00Z 2016-06-21T03:59:59Z 2016-06-21T13:00:21Z 2016-06360 0 0 0900006481ed5d78
FDA-2015-N-5017-0007 FDA None FDA-2015-N-5017 Reference 5 - Food and Drug Administration, Stratmeyer, M., T. Cunningham, A. Lowery, et al., Medical Glove Powder Report re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T18:34:34Z   0 0 0900006481ed709d
FDA-2015-N-5017-0016 FDA None FDA-2015-N-5017 Reference 14 - Sawyer, J. and A. Bennett, Comparing the Level of Dexterity Offered by Latex and Nitrile SafeSkin Gloves re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:02:01Z   0 0 0900006481ed70de
FDA-2015-N-5017-0008 FDA None FDA-2015-N-5017 Reference 6 - Draft Guidance for Industry and FDA Medical Glove Guidance Manual, issued July 30, 1999 withdrawn January re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T18:35:57Z   0 0 0900006481ed7372
FDA-2015-N-5017-0013 FDA None FDA-2015-N-5017 Reference 11 - Korniewicz, D.M., M. El-Masri, J.M. Broyles, et al., Performance of Latex and Nonlatex Medical Examination Gloves During Simulated Use re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T18:56:41Z   0 0 0900006481ed7379
FDA-2015-N-5017-0034 FDA None FDA-2015-N-5017 Reference 32 - Korniewicz, D.M., N. Chookaew, J. Brown, et al.,Conversion to Low-Protein, Powder-Free Surgical Gloves Is it Worth the Cost? re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T20:45:27Z   0 0 0900006481ed739c
FDA-2015-N-5017-0039 FDA None FDA-2015-N-5017 Reference 37 - Dwivedi, A.J., N.K. Kuwajerwala, Y.J. Silva, et al., Effects of surgical gloves on postoperative peritoneal adhesions and cytokine expression in a rat model re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T20:55:32Z   0 0 0900006481ed73a1
FDA-2015-N-5017-0019 FDA None FDA-2015-N-5017 Reference 17 - Cooke, S.A. and D.G. Hamilton, The Significance of Starch Powder Contamination in the Aetiology of Peritoneal Adhesions re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:06:41Z   0 0 0900006481ed70e1
FDA-2015-N-5017-0031 FDA None FDA-2015-N-5017 Reference 29 - Cuming, R.G., Reducing the Hazards of Exposure to Cornstarch Glove Powder, AORN Journal, 76(2)288-295, 20 re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:40:40Z   0 0 0900006481ed70f8
FDA-2015-N-5017-0033 FDA None FDA-2015-N-5017 Reference 31 - Jackson, E.M., J.A. Arnette, M.L. Martin, et al., A Global Inventory of Hospitals Using Powder-Free Gloves: A Search for Principled Medical Leadership re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T20:41:34Z   0 0 0900006481ed739b
FDA-2015-N-5017-0035 FDA None FDA-2015-N-5017 Reference 33 - Liss, G.M. and S.M. Tarlo, Natural Rubber Latex-Related Occupational Asthma Association With Interventions and Glove Changes Over Time re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T20:47:15Z   0 0 0900006481ed739d
FDA-2015-N-5017-0017 FDA None FDA-2015-N-5017 Reference 15 - Truscott, W., Glove Powder Reduction and Alternative Approaches, Methods, 27(1)69-76, 2002 re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:03:22Z   0 0 0900006481ed70df
FDA-2015-N-5017-0028 FDA None FDA-2015-N-5017 Reference 26 - Allmers, H., J. Schmengler, and S.M. John, Decreasing Incidence of Occupational Contact Urticaria Caused by Natural Rubber Latex Allergy in German Health Care Workers re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:34:46Z   0 0 0900006481ed70f5
FDA-2015-N-5017-0042 FDA None FDA-2015-N-5017 Reference 40 - Sjösten, A.C., H. Ellis, and G.A. Edelstam, Retrograde Migration of Glove Powder in the Human Female Genital Tract re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T21:01:53Z   0 0 0900006481ed7502
FDA-2015-N-5017-0012 FDA None FDA-2015-N-5017 Reference 10 - Kerr, L.N., M.P. Chaput, L.D. Cash, et al., Assessment of the Durability of Medical Examination Gloves re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T18:45:39Z   0 0 0900006481ed7376
FDA-2015-N-5017-0038 FDA None FDA-2015-N-5017 Reference 36 - Chegini, N. and H. Rong, Postoperative Exposure to Glove Powders Modulates Production of Peritoneal Eicosanoids During Peritoneal Wound Healing re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T20:53:12Z   0 0 0900006481ed73a0
FDA-2015-N-5017-0040 FDA None FDA-2015-N-5017 Reference 38 - Sjösten, A.C., H. Ellis, and G.A. Edelstam, Post-Operative Consequences of Glove Powder Used Pre-Operatively in the Vagina in the Rabbit Model re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T20:58:37Z   0 0 0900006481ed73a2
FDA-2015-N-5017-0006 FDA None FDA-2015-N-5017 Reference 4 - Ellis, H., Pathological Changes Produced by Surgical Dusting Powders, Annals of the Royal College of Surge re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T18:32:34Z   0 0 0900006481ed709c
FDA-2015-N-5017-0027 FDA None FDA-2015-N-5017 Reference 25 - Allmers, H., R. Brehler, Z. Chen, et al., Reduction of Latex Aeroallergens and Latex-Specific IgE Antibodies in Sensititized workers After Removal of Powered Natural Rubber Latex Glove in a Hospital re Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:31:10Z   0 0 0900006481ed70f2

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