ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD

ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD is an FDA 510(k)-cleared medical device (K081923) manufactured by Glaxosmithkline Consumer 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 June 30, 2009. Regulation: 8.