
O&M Halyard, Inc.
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Aero Blue Performance Surgical Gowns is an FDA 510(k)-cleared medical device (K192362) manufactured by O&M Halyard, 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 December 12, 2019. Regulation: 8.