BARRIER N95 PARTICULATE RESPIRATOR

BARRIER N95 PARTICULATE RESPIRATOR is an FDA 510(k)-cleared medical device (K102923) manufactured by Molnlycke Health Care. 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 18, 2010. Regulation: 8.