0910-AH02 201610 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Banned Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove

FDA has determined that a subset of surgeon and patient exam gloves that are powdered and that represent a modest share of the market present an unreasonable and substantial risk of illness or injury that cannot be corrected by a change in labeling. These gloves are powdered natural rubber latex surgeon's gloves, powdered synthetic latex surgeon's gloves, powdered natural rubber latex patient examination gloves, powdered synthetic patient examination gloves, and absorbable powder for lubricating a surgeon's glove. Consequently, FDA is banning these devices.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 878 21 CFR 880 21 CFR 895 21 U.S.C. 352 21 U.S.C. 360f 21 U.S.C. 360h 21 U.S.C. 360i 21 U.S.C. 371 ... No NPRM 03/18/2016 81 FR 15173 NPRM Comment Period End 06/20/2016 Final Action 01/00/2017 No Undetermined Undetermined No Yes Sonja Fulmer 0910 Food and Drug Administration FDA 240 402-5979 sonja.fulmer@fda.hhs.gov Center for Devices and Radiological Health, Building 66, Room 5244, 10903 New Hampshire Avenue, Silver Spring MD 20993