Medical Device Manufacturer · US , Alpharetta , GA

O&M Halyard, Inc. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 2019

Recent clearances: HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL), PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves, HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology

27
Total
27
Cleared
0
Denied

O&M Halyard, Inc. has 27 FDA 510(k) cleared general hospital devices. Based in Alpharetta, US.

Latest FDA clearance: Oct 2026. Active since 2019.

Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - O&M Halyard, Inc.

27 devices
1-12 of 27
Cleared Oct 28, 2026
HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL)
K260310 · QSO
General Hospital · 271d
Cleared Jul 21, 2026
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves
K262014 · LZA
General Hospital · 36d
Cleared Jul 02, 2026
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology
K261897 · FRG
General Hospital · 27d
Cleared May 18, 2026
HALYARD* ONE-STEP* Sterilization Wrap
K253454 · FRG
General Hospital · 227d
Cleared Mar 18, 2026
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO...
K251967 · FXX
General Hospital · 265d
Cleared Dec 11, 2025
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
K252941 · FXX
General Hospital · 87d
Cleared Aug 18, 2025
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis...
K243604 · LZA
General Hospital · 270d
Cleared Jun 18, 2025
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs
K243172 · LZA
General Hospital · 261d
Cleared Dec 17, 2024
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology,...
K242558 · LZA
General Hospital · 111d
Cleared Sep 27, 2024
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential,...
K241909 · LZA
General Hospital · 88d
Cleared Sep 16, 2024
HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization...
K234050 · FRG
General Hospital · 270d
Cleared Aug 07, 2024
HALYARD* SMART-FOLD* Sterilization Wrap (H450)
K240330 · FRG
General Hospital · 184d
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