High Fluid-Resistant Surgical and Procedure Mask

High Fluid-Resistant Surgical and Procedure Mask is an FDA 510(k)-cleared medical device (K222749) manufactured by America’S Supply Chains. 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 November 13, 2022. Regulation: 8.