View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
HHS/FDA | RIN: 0910-AH02 | Publication ID: Spring 2017 |
Title: Banned Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove | |
Abstract:
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: Completed Actions |
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 |
|||||||||||||||
Timetable:
|
Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
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 Email: sonja.fulmer@fda.hhs.gov |