FDA cleared the PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves from O&M Halyard, Inc. on Jul 21, 2026 under K262014, a special 510(k). The device falls under product code LZA, Polymer Patient Examination Glove, regulated at 21 CFR 880.6250 as a Class 1 device. The review panel was General Hospital.
FDA logged the submission as received on Jun 15, 2026. The decision came 36 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: K261897 (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), 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).