
O&M Halyard, Inc.
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HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops is an FDA 510(k)-cleared medical device (K252941) 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 10, 2025. Regulation: 8.