SECURE-GARD SURGICAL AND PROCEDURE FACE MASK

SECURE-GARD SURGICAL AND PROCEDURE FACE MASK is an FDA 510(k)-cleared medical device (K140155) manufactured by Cardinal Health200, 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 June 19, 2014. Regulation: 8.