
Owens & Minor (O&M) Halyard, Inc.
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HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is an FDA 510(k)-cleared medical device (K232820) manufactured by Owens & Minor (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 June 3, 2024. Regulation: 8.