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Hong YA Non-Woven Products Co., Ltd.
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SURGICAL FACE MASK is an FDA 510(k)-cleared medical device (K060776) manufactured by Hong YA Non-Woven Products Co., Ltd.. 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 May 24, 2006. Regulation: 8.