Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria
fda-device · Food and Drug Administration · Rule · Published 2006-12-19 · Effective 2008-12-19 · 71 FR 75865
Document
Document number
E6-21591
Federal Register citation
71 FR 75865
CFR reference
21 CFR 800
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2006-12-19
Effective date
2008-12-19
HHS docket
Docket No. 2003N-0056 (formerly 03N-0056)
Abstract
The Food and Drug Administration (FDA) is issuing a final rule to improve the barrier quality of medical gloves marketed in the United States. The rule will accomplish this by reducing the current acceptable quality levels (AQLs) for leaks and visual defects observed during FDA testing of medical gloves. By reducing the AQLs for medical gloves, FDA will also harmonize its AQLs with consensus standards developed by the International Organization for Standardization (ISO) and ASTM International (ASTM).