Biogel PI Micro Indicator Underglove

Biogel PI Micro Indicator Underglove is an FDA 510(k)-cleared medical device (K150146) 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 August 30, 2015. Regulation: 8.