510(k) K252941

HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops by O&M Halyard, Inc. — Product Code FXX

K252941 is an FDA 510(k) premarket notification submitted by O&M Halyard, Inc. for the device "HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops". The FDA issued a decision of Substantially Equivalent on December 11, 2025. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. O&M Halyard, Inc. has at least 10 other 510(k) clearances on record.