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FDA changes the AQL for the examination of Gloves

Please be aware that the FDA is going to change the AQL for patient examination gloves and surgeon gloves making it much tighter.

On December 19, 2008 the new rule (21 CFR 800.20) regarding FDA sample plans and test methods for Patient Examination Gloves and Surgeon's Gloves will take effect. The most significant change in this rule is that the Acceptable Quality Levels (AQL) that FDA uses to evaluate medical gloves marketed in the United States will change from 4.0 to 2.5 for Patient Examination Gloves and from 2.5 to 1.5 for Surgeon's Gloves. FDA published the final rule in the Federal Register on December 19, 2006 with a two-year interval prior to the effective date.

We expect that FDA will start to test and evaluate shipments of gloves introduced into commerce in the United States using the new AQLs in January 2009. We also expect that since the AQLs are now more restrictive, this could result in more glove shipments being declared adulterated. Before submitting further medical glove shipments for entry, you should take appropriate steps to assure that your manufacturing and quality practices are adequate to produce gloves that are consistently below the new AQLs.

For more information on this please contact mdi at info@mdiconsultants.com.

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