Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove
other · Food and Drug Administration · Rule · Published 2016-12-19 · Effective 2017-01-18 · 81 FR 91722
Document
Document number
2016-30382
Federal Register citation
81 FR 91722
CFR reference
21 CFR 878
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2016-12-19
Effective date
2017-01-18
HHS docket
Docket No. FDA-2015-N-5017
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 banning these devices.