MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95

MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 is an FDA 510(k)-cleared medical device (K020474) manufactured by Makrite Industries, Inc.. 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 22, 2002. Regulation: 8.