BIOGEL ORTHOPRO INDICATOR UNDERGLOVE

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.