HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology

FDA cleared the HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology from O&M Halyard, Inc. on Jul 2, 2026 under K261897, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code FRG, Wrap, Sterilization, regulated at 21 CFR 880.6850 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jun 5, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

O&M Halyard, Inc. has 4 other decisions in the tracker over the last 12 months: K262014 (PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves), K253454 (HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap), 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), K252941 (HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops).