
Molnlycke Health Care Us, LLC
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BIOGEL ORTHOPOR BROWN SURGICAL GLOVE is an FDA 510(k)-cleared medical device (K112089) manufactured by Molnlycke Health Care Us, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 23, 2011. Regulation: 8.