Secure Wear USA Surgical Face Mask

Secure Wear USA Surgical Face Mask is an FDA 510(k)-cleared medical device (K203101) manufactured by Secured Ortho Manufacturing of America, 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 March 30, 2021. Regulation: 8.