Final FDA Ruling On Exam Gloves
On December 9, 2006, the Food and Drug Administration (FDA) announced its final ruling on test procedures and minimum acceptable criteria for surgical and exam gloves.
One of the most important aspects of the rule involves increasing the accepted barrier quality of medical and exam gloves sold in the United States. Per the FDA:
“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 final rule becomes effective on December 19, 2008.




