BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES

BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES is an FDA 510(k)-cleared medical device (K140477) 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 March 22, 2015. Regulation: 8.