O&M Halyard, Inc. FDA Approvals

0 new drug approvals and 20 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves510(k)Jul 21, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Jul 21, 2026
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* Technology510(k)Jul 2, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 2, 2026
HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap510(k)May 18, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	May 18, 2026
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 Visor510(k)Mar 18, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Mar 18, 2026
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops510(k)Dec 11, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Dec 11, 2025
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid510(k)Aug 18, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Abbreviated)	Aug 18, 2025
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles510(k)Jun 18, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Abbreviated)	Jun 18, 2025
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid510(k)Dec 17, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Abbreviated)	Dec 17, 2024
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid510(k)Sep 27, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Abbreviated)	Sep 27, 2024
HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap510(k)Sep 16, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Sep 16, 2024
HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)510(k)Aug 7, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 7, 2024
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid510(k)Mar 22, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Abbreviated)	Mar 22, 2024
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution510(k)Aug 16, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Abbreviated)	Aug 16, 2022
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid510(k)Aug 1, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Abbreviated)	Aug 1, 2022
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves510(k)Jun 2, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Jun 2, 2022
PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves510(k)Jun 2, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Jun 2, 2022
Sterisystem Dry-Base Instrument Tray510(k)Jan 2, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jan 2, 2022
HALYARD Flexaprene Green Powder-Free Exam Glove510(k)Nov 19, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Abbreviated)	Nov 19, 2021
AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown510(k)Jul 21, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Abbreviated)	Jul 21, 2021
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate510(k)Jan 7, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Abbreviated)	Jan 7, 2021

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