{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is proposing these devices be banned.","action":"Proposed rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/03/22/2016-06360.html","cfr_references":[{"chapter":null,"citation_url":null,"part":878,"title":21},{"chapter":null,"citation_url":null,"part":880,"title":21},{"chapter":null,"citation_url":null,"part":895,"title":21}],"citation":"81 FR 15173","comment_url":null,"comments_close_on":"2016-06-20","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by June 20, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-5017"],"dockets":[{"supporting_documents":[{"title":"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 Lub","document_id":"FDA-2015-N-5017-0192"},{"title":"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 Lubricatin","document_id":"FDA-2015-N-5017-0189"},{"title":"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","document_id":"FDA-2015-N-5017-0187"},{"title":"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 Gl","document_id":"FDA-2015-N-5017-0185"},{"title":"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 Lub","document_id":"FDA-2015-N-5017-0184"},{"title":"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 Glov","document_id":"FDA-2015-N-5017-0175"},{"title":"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","document_id":"FDA-2015-N-5017-0073"},{"title":"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","document_id":"FDA-2015-N-5017-0068"},{"title":"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","document_id":"FDA-2015-N-5017-0067"},{"title":"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","document_id":"FDA-2015-N-5017-0065"}],"agency_name":"FDA","documents":[{"comment_count":95,"comment_start_date":"2016-03-22","updated_at":"2023-02-28T16:20:17.161-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-N-5017-0001","allow_late_comments":null,"id":"FDA-2015-N-5017-0001","comment_end_date":"2016-06-21","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":99,"id":"FDA-2015-N-5017","title":"Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove"}],"document_number":"2016-06360","effective_on":null,"end_page":15188,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/03/22/2016-06360.xml","html_url":"https://www.federalregister.gov/documents/2016/03/22/2016-06360/banned-devices-proposal-to-ban-powdered-surgeons-gloves-powdered-patient-examination-gloves-and","images":{"EP22MR16.001":{"large":"https://img.federalregister.gov/EP22MR16.001/EP22MR16.001_large.png","original_size":"https://img.federalregister.gov/EP22MR16.001/EP22MR16.001_original_size.png"}},"images_metadata":{"EP22MR16.001":{"large":{"identifier":"EP22MR16.001","content_type":"image/png","size":30796,"width":823,"sha":"bbe03f327db82593b7a18cd0e9a778bd","url":"https://img.federalregister.gov/EP22MR16.001/EP22MR16.001_large.png","height":495},"original_size":{"identifier":"EP22MR16.001","content_type":"image/png","size":18349,"width":1951,"sha":"b9e8e5762e1f1693ea5234ce14e42351","url":"https://img.federalregister.gov/EP22MR16.001/EP22MR16.001_original_size.png","height":1173}}},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-06360?publication_date=2016-03-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-03-22/2016-06360/mods.xml","not_received_for_publication":null,"page_length":16,"page_views":{"count":7658,"last_updated":"2026-10-23 12:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-03-22/pdf/2016-06360.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-06360.pdf?1458564364","publication_date":"2016-03-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/03/22/2016-06360.txt","regulation_id_number_info":{"0910-AH02":{"issue":"201610","html_url":"https://www.federalregister.gov/regulations/0910-AH02/banned-powdered-surgeon-s-gloves-powdered-patient-examination-gloves-and-absorbable-powder-for-lubri","title":"Banned Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove ","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201610&RIN=0910-AH02&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH02"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"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 Lub","document_id":"FDA-2015-N-5017-0192"},{"title":"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 Lubricatin","document_id":"FDA-2015-N-5017-0189"},{"title":"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","document_id":"FDA-2015-N-5017-0187"},{"title":"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 Gl","document_id":"FDA-2015-N-5017-0185"},{"title":"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 Lub","document_id":"FDA-2015-N-5017-0184"},{"title":"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 Glov","document_id":"FDA-2015-N-5017-0175"},{"title":"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","document_id":"FDA-2015-N-5017-0073"},{"title":"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","document_id":"FDA-2015-N-5017-0068"},{"title":"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","document_id":"FDA-2015-N-5017-0067"},{"title":"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","document_id":"FDA-2015-N-5017-0065"}],"comments_count":95,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-5017","supporting_documents_count":99,"docket_id":"FDA-2015-N-5017","document_id":"FDA-2015-N-5017-0001","regulation_id_number":null,"title":"Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove","checked_regulationsdotgov_at":"2023-02-28T21:20:16Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":15173,"subtype":null,"title":"Banned Devices; Proposal To Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove","toc_doc":"Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove","toc_subject":"Banned Devices:","topics":["Administrative practice and procedure","Labeling","Medical devices"],"type":"Proposed Rule","volume":81}