Paneffort 3-ply Surgical and Procedural Masks

Paneffort 3-ply Surgical and Procedural Masks is an FDA 510(k)-cleared medical device (K221409) manufactured by Paneffort, 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 July 24, 2022. Regulation: 8.