VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL

VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL is an FDA 510(k)-cleared medical device (K992081) manufactured by Suretex Prophylactics (India) , Ltd.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 18, 1999. Regulation: 8.