REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE

REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE is an FDA 510(k)-cleared medical device (K970924) manufactured by 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 March 31, 1997. Regulation: 8.