GLOVE-N-GEL AMNIOTOMY KIT

GLOVE-N-GEL AMNIOTOMY KIT is an FDA 510(k)-cleared medical device (K910518) manufactured by Epcom Medical Systems, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 8, 1991. Regulation: 8.