Biodegradable Thermoplastic Elastomer Examination (TPE) Glove

Biodegradable Thermoplastic Elastomer Examination (TPE) Glove is an FDA 510(k)-cleared medical device (K202078) manufactured by Shen Wei USA, Inc.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 4, 2021. Regulation: 8.