O&M Halyard, Inc.
Alpharetta, GA, US
O&M Halyard, Inc. appears in FDA device records in Alpharetta, GA. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for O&M Halyard, Inc. between 2019 and 2026. The busiest year on record is 2022, with 5. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 4 |
| 2020 | 2 |
| 2021 | 3 |
| 2022 | 5 |
| 2024 | 5 |
| 2025 | 3 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | LZA | Substantially Equivalent | |
| 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 | FRG | Substantially Equivalent | |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap | FRG | Substantially Equivalent | |
| 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 | FXX | Substantially Equivalent | |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | FXX | Substantially Equivalent | |
| 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 | LZA | Substantially Equivalent | |
| K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles | LZA | Substantially Equivalent | |
| 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 | LZA | Substantially Equivalent | |
| K241909 | 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 Acid | LZA | Substantially Equivalent | |
| K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap | FRG | Substantially Equivalent | |
| K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) | FRG | Substantially Equivalent | |
| K231938 | 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 Acid | LZA | Substantially Equivalent | |
| K213937 | 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 Solution | LZA | Substantially Equivalent | |
| 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 | LZA | Substantially Equivalent | |
| K220547 | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves | LZA | Substantially Equivalent | |
| K220541 | PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves | LZA | Substantially Equivalent | |
| K203177 | Sterisystem Dry-Base Instrument Tray | KCT | Substantially Equivalent | |
| K211063 | HALYARD Flexaprene Green Powder-Free Exam Glove | LZA | Substantially Equivalent | |
| K210688 | AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown | FYA | Substantially Equivalent | |
| K202622 | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate | LZA | Substantially Equivalent | |
| K200843 | Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs | LZA | Substantially Equivalent | |
| K200522 | AERO CHROME* Breathable Performance Surgical Gowns | FYA | Substantially Equivalent | |
| K192362 | Aero Blue Performance Surgical Gowns | FYA | Substantially Equivalent | |
| K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | LZC | Substantially Equivalent | |
| K182851 | SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | |
| K183132 | Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014421917 | 3014421917 | O&M Halyard, Inc. | 1220 Old Alpharetta Rd Ste 320, Alpharetta, GA 30005 US | 2026 | and 117 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IKXAid, Transfer
- CAEAirway, Oropharyngeal, Anesthesiology
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- EZSAppliance, Colostomy, Disposable
- INBAttachment, Commode, Wheelchair
- DSWBag, Polymeric Mesh, Pacemaker
- GDSBag, Stomal
- FQMBandage, Elastic
- FNYBasin, Emesis
- FNLBed, Ac-Powered Adjustable Hospital
- DXQBlood Pressure Cuff
- FYFCap, Surgical
- EZDCatheter, Straight
- BSYCatheters, Suction, Tracheobronchial
- HFWClamp, Umbilical
- GCDConnector, Catheter
- FMHContainer, Specimen, Sterile
- FXPCover, Shoe, Operating-Room
- EXIDevice, Paste-On For Incontinence, Sterile
- FRODressing, Wound, Drug
- DRXElectrode, Electrocardiograph
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FRLFiber, Medical, Absorbent
- CAHFilter, Bacterial, Breathing-Circuit
- EYQGarment, Protective, For Incontinence
- GDYGauze/Sponge, Internal, X-Ray Detectable
- FMEGown, Examination
- FYCGown, Isolation, Surgical
- FYAGown, Surgical
- EYJHolder, Ureteral Catheter
- FRCIndicator, Biological Sterilization Process
- FXXMask, Surgical
- CAFNebulizer (Direct Patient Interface)
- FMINeedle, Hypodermic, Single Lumen
- IMDPack, Hot Or Cold, Disposable
- IMEPack, Hot Or Cold, Reusable
- DSFRecorder, Paper Chart
- FMQRestraint, Protective
- HDJScissors, Umbilical
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- BWPShoe And Shoe Cover, Conductive
- ILISling, Arm
- HIBSpeculum, Vaginal, Nonmetal
- ILHSplint, Hand, And Components
- FOXStand, Infusion
- FXOSuit, Surgical
- CCXSupport, Patient Position
- FMFSyringe, Piston
- DWJSystem, Thermal Regulating
- BWNTable And Attachments, Operating-Room
- INPTips And Pads, Cane, Crutch And Walker
- EFWToothbrush, Manual
- GAXTourniquet, Nonpneumatic
- BYZTrap, Sterile Specimen
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- FSMTray, Surgical, Instrument
- BYYTube, Aspirating, Flexible, Connecting
- FPDTube, Feeding
- FRGWrap, Sterilization
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2230-2026 | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl) | Nitrile Exam Glove failed to meet specifications chemical permeation performance. | Class II | Open, Classified | |
| Z-2520-2025 | Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029 | Surgical drape packs may have open seals, which may compromise the sterility of the product. | Class II | Open, Classified | |
| Z-0983-2025 | Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A | Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. | Class II | Open, Classified | |
| Z-0729-2025 | O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500 | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required. | Class II | Open, Classified | |
| Z-0728-2025 | O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117 | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required. | Class II | Open, Classified | |
| Z-1461-2024 | HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) | Product was mislabeled as a Surgical Cap at its dispenser level. | Class III | Open, Classified | |
| Z-2626-2023 | FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827 | One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user. | Class II | Open, Classified | |
| Z-0317-2022 | HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL | All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain