
Molnlycke Health Care, Inc.
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KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION is an FDA 510(k)-cleared medical device (K000901) manufactured by Molnlycke Health Care, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 4, 2000. Regulation: 8.