View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AH02 Publication ID: Fall 2016 
Title: 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.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 878    21 CFR 880    21 CFR 895   
Legal Authority: 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    ...   
Legal Deadline:  None
Action Date FR Cite
NPRM  03/18/2016  81 FR 15173   
NPRM Comment Period End  06/20/2016 
Final Action  01/00/2017 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
Sonja Fulmer
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, Building 66, Room 5244, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:240 402-5979