BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT

BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT is an FDA 510(k)-cleared medical device (K071565) 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 9, 2007. Regulation: 8.