0910-AH02 201504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Proposal to Ban Powdered Natural Rubber Latex and Powdered Synthetic Latex Surgeon's and Patient Examination Gloves

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 a substantial risk of illness 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 proposing to ban these devices.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed 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 07/00/2015 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