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HHS/FDA RIN: 0910-AC32 Publication ID: Spring 2002 
Title: ●Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration 
Abstract: The Food and Drug Administration (FDA) is proposing to amend the sampling plans, test method, and acceptable quality levels in 21 CFR 800.20. As prescribed by this regulation, FDA samples patient examination and surgeons' gloves and examines them for visual defects and water leaks. Glove lots are considered adulterated if they do not meet specified quality levels. This proposal would clarify sampling plans and the scoring of defects, lower acceptance rates for leaking gloves, raise rejection rates for leaking gloves, and add tightened inspection schemes for reexamined glove lots. The rule is intended to facilitate industry compliance and enhance the safety and effectiveness of gloves. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 800.20   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351    21 USC 352    21 USC 371    21 USC 374   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2002    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Joseph M. Sheehan
Chief, Regulations Staff
Department of Health and Human Services
Food and Drug Administration
HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive,
Rockville, MD 20850
Phone:301 827-2974
Fax:301 594-4765
Email: joseph.sheehan@fda.hhs.gov