3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is an FDA 510(k)-cleared medical device (K180874) manufactured by 3M Healthcare. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 30, 2018. Regulation: 8.