# Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria; Correction
> **Food and Drug Administration** · Final rule; correction. · Published 2007-01-19 · Effective 2007-01-19 · 72 FR 2436
## Document
- **Document number:** E7-682
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 72 FR 2436
- **CFR reference:** 21 CFR 800
- **Publication date:** 2007-01-19
- **Effective date:** 2007-01-19
- **HHS docket:** Docket No. 2003N-0056 (formerly 03N-0056)
## Abstract

The Food and Drug Administration (FDA) is correcting a final regulation that appeared in the Federal Register of December 19, 2006 (71 FR 75865). The document issued a final regulation that improves the barrier quality of medical gloves marketed in the United States (U.S.). 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). The document was published with some errors in the use of references. This document corrects those errors.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2007/01/19/E7-682/medical-devices-patient-examination-and-surgeons-gloves-test-procedures-and-acceptance-criteria)
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