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HHS/FDA

RIN: 0910-AC32

Publication ID: Spring 2007

Title: Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria
Abstract: The final rule amends the sampling plans, test method, and acceptable quality levels in 21 CFR part 800.20 in accordance with which FDA tests patient examination and surgeons' gloves for barrier integrity. 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 rule will 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 enhance the safety and effectiveness of gloves and harmonize acceptable quality levels with international consensus standards.
Agency: Department of Health and Human Services(HHS)	Priority: Routine and Frequent
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Completed Actions
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 800.20
Legal Authority: 21 USC 321 21 USC 334 21 USC 351 21 USC 352 21 USC 360e 21 USC 360i 21 USC 360k 21 USC 361 21 USC 362

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	03/31/2003	68 FR 15404
NPRM Comment Period End	06/30/2003
Final Action	12/19/2006	71 FR 75865

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Federalism: No
Included in the Regulatory Plan: No
Agency Contact: Madhusoodana Nambiar Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, WO 66, Room 5518, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-5837 Fax:301 847-8145 Email: madhusoodana.nambiar@fda.hhs.gov