Initially, the FDA focused only on regulating drugs. Now FDA regulations provide for the security, effectiveness, and proper use of all medical devices –including disposable medical gloves.
The FDA itself doesn’t really compose standards for medical devices. On the contrary, it acknowledges guidelines written by other people, like the American Society of Testing and Materials (ASTM), the American Association of Medical Instrumentation (AAMI) and United States Pharmacopoeia (USP). FDA representatives do participate in standard-writing committees.
Frequently, the FDA employs the standards that are established as baseline conditions when evaluating supplies and medical devices for the marketplace. As an example, the FDA requires all medical glove producers to meet with ASTM guideline D 5151 for the detection of holes in disposable exam gloves.