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Glaxosmithkline Consumer Healthcare
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ACTIPROTECT UF N95 RESPIRATOR is an FDA 510(k)-cleared medical device (K093161) 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 May 9, 2010. Regulation: 8.