3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S

3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S is an FDA 510(k)-cleared medical device (K171116) manufactured by 3M Healthcare. 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 August 9, 2017. Regulation: 8.