Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask is an FDA 510(k)-cleared medical device (K202595) manufactured by Premier Guard USA, LLC. 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 January 20, 2021. Regulation: 8.