CLEAR POROUS PLASTIC-HYPOALLERGENIC

CLEAR POROUS PLASTIC-HYPOALLERGENIC is an FDA 510(k)-cleared medical device (K840948) manufactured by Gainor Medical. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 1984. Regulation: 8.