BIOGEL (R) INDICATOR (R) UNDERGLOVE

BIOGEL (R) INDICATOR (R) UNDERGLOVE is an FDA 510(k)-cleared medical device (K111413) 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 January 29, 2012. Regulation: 8.