
Nat'L Surtex Corp.
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DISPOSABLE ISOLATION GOWN is an FDA 510(k)-cleared medical device (K921058) manufactured by Nat'L Surtex Corp.. 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 August 10, 1992. Regulation: 8.