PATIENT PREP KITS/TRAYS-STERILE

PATIENT PREP KITS/TRAYS-STERILE is an FDA 510(k)-cleared medical device (K821044) manufactured by Phoenix Glove Co.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 22, 1982. Regulation: 8.