SKINSENSE POLYISOPRENE UNDERGLOVE

SKINSENSE POLYISOPRENE UNDERGLOVE is an FDA 510(k)-cleared medical device (K081180) 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 25, 2008. Regulation: 8.