510(k) K232894

HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) by Owens & Minor (O&M) Halyard, Inc. — Product Code FXX

K232894 is an FDA 510(k) premarket notification submitted by Owens & Minor (O&M) Halyard, Inc. for the device "HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)". The FDA issued a decision of Substantially Equivalent on January 8, 2024. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Owens & Minor (O&M) Halyard, Inc. has at least 10 other 510(k) clearances on record.