PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S

PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S is an FDA 510(k)-cleared medical device (K041855) manufactured by Aearo Co.. 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 November 9, 2004. Regulation: 8.