FDA Requirements - Surgical Medical Gloves

Medical gloves are manufacturered world-wide. To ensure manufacturers produce quality products, the Food and Drug Administration (FDA) governs manufacturing standards for surgical gloves. This ensures that protective gloves used for medical purposes meet certain performance criteria such as leak resistance and barrier strength. To put it simply, there are a set of tests called ASTM Standards for medical gloves which include exam gloves and surgical gloves. ASTM Standards give guidance to manufacturers on the minimum standards needed to call gloves surgical or exam by testing physical properties such as the ability to stretch the gloves before breaking and testing to see how many gloves on a production line have holes by conducting water leak tests.

FDA Requirements - ASTM Standards for Surgical Gloves

  • AQL Level for Holes - 1.5
  • Tensile Strength (before aging) - 24MPa
  • Tensile Strength (after aging) - 18 Mpa
  • Elongation (before aging) - 750%
  • Elongation (after aging) - 550%

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