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Molnlycke Health Care
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BARRIER SURGICAL GOWNS is an FDA 510(k)-cleared medical device (K050786) 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 May 8, 2005. Regulation: 8.