FDA Proposes Amendments to Regulation of Medical Glove Testing

WASHINGTON -- The Food and Drug Administration (FDA) is proposing the amendment of its regulation on medical glove testing by implementing stricter acceptable quality levels (AQLs).

The amendment, which also would affect the sampling plans and test methods of medical glove testing, would improve the barrier quality of medical gloves in the domestic market, and would harmonize better with consensus standards.

Currently, In accordance with the regulation, the FDA examines the gloves for visual defects and water leaks, which are considered adulterated if they do not meet certain quality levels. The proposed update would reduce what the FDA considers an acceptable level of defects.

If the proposed amendment is accepted, the new AQLs would better harmonize with standards developed by the International Organization for Standardization and the American Society for Testing Materials.

The FDA requests all written or electronic comments to be submitted by June 30, 2003. For more information, see the proposed rule at http://www.fda.gov/OHRMS/DOCKETS/98fr/ 03-7601.html.