510(k) K251967

HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor by O&M Halyard, Inc. — Product Code FXX

K251967 is an FDA 510(k) premarket notification submitted by O&M Halyard, Inc. for the device "HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor". The FDA issued a decision of Substantially Equivalent on March 18, 2026. 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.