
Molnlycke Health Care USA
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BIOGEL ORTHOPRO INDICATOR UNDERGLOVE is an FDA 510(k)-cleared medical device (K101163) manufactured by Molnlycke Health Care USA. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 22, 2010. Regulation: 8.