Puravita Medical Fold Flat Surgical Mask

Puravita Medical Fold Flat Surgical Mask is an FDA 510(k)-cleared medical device (K212740) manufactured by Puravita M, 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 December 1, 2021. Regulation: 8.