Update: August 19, 2022: If manufacturers are considering seeking 510(k) clearance for personal protective equipment, most masks (such as product code FXX) and gloves (such as product codes LYY, LYZ, LZA, KGO, and LZC) are eligible for 510(k) Third Party Review.
The FDA posted the following 510(k) review memos to assist Third Party Review Organizations. The FDA cannot share proprietary information, but the FDA is creating a library of redacted memos for selected devices with a high volume of third-party reviews. This commitment is described in Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews (PDF - 223KB).
- Surgical mask 510(k) review memo (redacted PDF)
- Vinyl Patient Examination Glove 510(k) review memo (redacted PDF)