# O&M Halyard, Inc.

- Location (FDA's records): Alpharetta, GA
- FDA decisions: 26 (2019–2026): 26 510(k) clearances
- Product codes: LZA (14), FRG (4), FYA (3), FXX (2), LZC (2), KCT (1)
- 510(k) review time since 2016: median 180 days, against 111 for FDA's reviews in the same codes and years (11 of 26 faster)
- Predicates its devices cite: 25 (9 its own); citations of its devices by later devices: 13 (9 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Halyard Health, Inc.: 5 (https://510kreport.com/company/halyard-health)
- Kimberly-Clark Corp.: 4 (https://510kreport.com/company/kimberly-clark)
- 0 & M Halyard, Inc.: 2 (https://510kreport.com/company/0-m-halyard)
- Owens & Minor (O&M) Halyard, Inc.: 2 (https://510kreport.com/company/owens-minor-o-m-halyard)
- Summit Glove, Inc.: 1 (https://510kreport.com/company/summit-glove)
- Owens & Minor Halyard, Inc.: 1 (https://510kreport.com/company/owens-minor-halyard)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Firms that cite its devices most
- Kl-Kepong Rubber Products Sdn. Bhd.: 2 (https://510kreport.com/company/kl-kepong-rubber-products-sdn-bhd)
- Jr Engineering & Medical Technologies (M) Sdn. Bhd.: 1 (https://510kreport.com/company/jr-engineering-medical-technologies-m-sdn-bhd)
- Hindernis DE Mexico, S.A.P.I. DE C.V.: 1 (https://510kreport.com/company/hindernis-de-mexico-sapi)

## Its most-cited devices
- K200522: AERO CHROME* Breathable Performance Surgical Gowns (2020), cited by 2
- K191230: Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves (2019), cited by 2
- K202622: Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate (2021), cited by 2
- K234050: HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap (2024), cited by 2
- K213929: Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (2022), cited by 1
- K220547: PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves (2022), cited by 1

## Recent decisions
- K262014: PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves (Jul 21, 2026)
- 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 (Jul 2, 2026)
- K253454: HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL  Sterilization Wrap; HALYARD* SMART-FOLD*  Sterilization Wrap (May 18, 2026)
- 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 (Mar 18, 2026)
- K252941: HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (Dec 11, 2025)
- K243604: 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 Acid (Aug 18, 2025)
- K243172: Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles (Jun 18, 2025)
- K242558: 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 Acid (Dec 17, 2024)

Source page: https://510kreport.com/company/o-m-halyard