SENSICARE SYNTHETIC, SURGICAL GLOVE LINER

SENSICARE SYNTHETIC, SURGICAL GLOVE LINER is an FDA 510(k)-cleared medical device (K950995) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 27, 1995. Regulation: 8.