Medical devices; patient examination and surgeons' gloves; test procedures and acceptance criteria. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to improve the barrier quality of medical gloves marketed in the United States. 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).
D003362:Cost-Benefit Analysis; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards*; D018562:Disease Transmission, Infectious / Q000517:prevention & control; D004867:Equipment Design / Q000592:standards; D004869:Equipment Safety / Q000592:standards*; D005932:Gloves, Surgical / Q000191:economics / Q000592:standards*; D006801:Humans; D008422:Materials Testing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration