BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE

BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE is an FDA 510(k)-cleared medical device (K112257) 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 September 19, 2011. Regulation: 8.