FDA Publishes Final Rule on Accepted Criteria for Gloves

The Food and Drug Administration (FDA) published its final rule in the Dec. 19, 2006 Federal Register on test procedures and accepted criteria for patient examination and surgeons' gloves.

The rule will improve the barrier quality of medical gloves marketed in the United States by reducing the current acceptable quality levels (AQLs) for leaks and visual defects observed during FDA testing of medical gloves," the FDA said. By reducing the AQLs for medical gloves, the FDA also expects to harmonize its AQLs with consensus standards developed by the International Organization for Standardization and American Society for Testing and Materials International.

The final rule will result in public health gains by reducing the frequency of bloodborne pathogen transmissions due to defects in the barrier protection provided by medical gloves, the agency said. Further, the FDA expects "an annualized monetary benefit of $14.8 million (using a 3 percent discount rate) or $15.1 million (using a 7 percent discount rate) will be realized due to fewer pathogen transmissions and unnecessary blood screens."

The final rule will become effective on Dec. 19, 2008. It can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/2003n-0056-nfr0001.pdf. Look for an article on this topic in the February 2007 issue of ICT.