510(k) K232812

Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) by Owens & Minor (O&M) Halyard, Inc. — Product Code FXX

K232812 is an FDA 510(k) premarket notification submitted by Owens & Minor (O&M) Halyard, Inc. for the device "Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)". The FDA issued a decision of Substantially Equivalent on June 14, 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.