IFM Surgical Mask Model SM3

IFM Surgical Mask Model SM3 is an FDA 510(k)-cleared medical device (K202214) manufactured by Fssc, 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 1, 2021. Regulation: 8.