BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE

BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE is an FDA 510(k)-cleared medical device (K053442) manufactured by Regent Medical Americas, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 6, 2006. Regulation: 8.