REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE

REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE is an FDA 510(k)-cleared medical device (K951908) manufactured by Regent Hospital Products. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 31, 1995. Regulation: 8.