Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria; Correction

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.