What type of testing is required for a medical glove to receive a 510(k) clearance?
A 510(k) is a premarket submission made to FDA to demonstrate that the medical glove to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed medical glove. Medical gloves must be biologically compatible with human skin. To assess this, the FDA requires two biological tests: Primary skin irritation (PSI), …
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