BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE

BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE is an FDA 510(k)-cleared medical device (K000421) manufactured by Ssl Americas, Inc. (Regent Medical). This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 13, 2000. Regulation: 8.