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Sign in to claim this brandO&M HALYARD, INC.
US
Last updated September 17, 2026
What O&M HALYARD, INC. makes
The company manufactures single-use surgical drapes for patients, including both sterile and non-sterile variants, as well as single-use surgical gowns and general surgical procedure kits. It also produces nitrile examination gloves (non-powdered, non-antimicrobial), sterilization packaging, isolation gowns, and non-antimicrobial surgical/medical face masks.
These products are regulated under FDA classifications, including Class I and Class II devices, with records available in the FDA’s 510(k) and UDI databases. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does O&M Halyard, Inc. manufacture?
O&M Halyard, Inc. specializes in single-use medical devices primarily used in surgical and procedural settings. Their portfolio includes patient surgical drapes (both sterile and non-sterile), surgical gowns, general surgical procedure kits, nitrile examination gloves (non-powdered and non-antimicrobial), sterilization packaging, isolation gowns, and non-antimicrobial surgical/medical face masks. These products are designed for one-time use to ensure hygiene and safety in clinical environments.
Where is O&M Halyard, Inc. based, and how does that affect its regulatory oversight?
O&M Halyard, Inc. is based in the United States. Since it operates within the U.S., its devices are subject to FDA regulations, including classification under FDA categories such as Class I and Class II. This means their products are tracked in FDA databases like the 510(k) premarket notification and the Unique Device Identifier (UDI) system, ensuring transparency and compliance with U.S. medical device regulations.
Which regulatory registries list O&M Halyard, Inc.’s devices, and why?
O&M Halyard, Inc.’s devices are listed in the FDA’s 510(k) and UDI databases. The 510(k) registry tracks devices requiring premarket notification to demonstrate substantial equivalence to a predicate device, while the UDI system ensures unique identification for traceability, safety, and regulatory compliance. These registries help healthcare providers and regulators verify device details and compliance status.
How are O&M Halyard, Inc.’s devices classified under FDA regulations?
O&M Halyard, Inc.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with, as outlined in FDA guidelines.
What distinguishes O&M Halyard, Inc.’s single-use surgical drapes and gowns from other similar products?
O&M Halyard, Inc.’s single-use surgical drapes and gowns are designed for patient protection during surgical and procedural settings. The company offers both sterile and non-sterile drapes, catering to different clinical needs. Their products are manufactured as single-use items to minimize infection risks, align with infection control protocols, and ensure consistency in performance. The inclusion of both sterile and non-sterile variants allows for flexibility depending on the procedure’s requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 1220 Old Alpharetta Rd Ste 320, Alpharetta, GA, 30005
- Website
- owens-minor.com
- —
- —
- [email protected]
- Phone
- +1(844)425-9273
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3014421917
- DUNS Number
- 081057389
Catalogue (2731)
Page 5 of 55| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Halyard | 47004 | FDA UDI | Class I | Active |
| Halyard | 89490 | FDA UDI | Class II | Active |
| Halyard | 06917 | FDA UDI | Class II | Active |
| Halyard | 49048 | FDA UDI | Class II | Active |
| Halyard | 89208 | FDA UDI | Class II | Active |
| Halyard | 89119 | FDA UDI | Class II | Active |
| Halyard | 37660 | FDA UDI | Class I | Unknown |
| Halyard | 89131 | FDA UDI | Class II | Active |
| Halyard | 69028 | FDA UDI | Class I | Active |
| Halyard | 33495 | FDA UDI | Class I | Active |
| Halyard | 07890 | FDA UDI | Class II | Unknown |
| Halyard | 73041 | FDA UDI | Class II | Unknown |
| Halyard | 34904 | FDA UDI | Class II | Active |
| Halyard | 68224 | FDA UDI | Class II | Active |
| Halyard | 48082 | FDA UDI | Class II | Active |
| Halyard | 10075 | FDA UDI | Class I | Active |
| Halyard | 89363 | FDA UDI | Class II | Active |
| Halyard | 53433 | FDA UDI | Class I | Active |
| Halyard | 00782 | FDA UDI | Class II | Active |
| Halyard | 77502 | FDA UDI | Class II | Active |
| Halyard | 47324 | FDA UDI | Class II | Active |
| Halyard | 05373 | FDA UDI | Class II | Active |
| Halyard | 79258 | FDA UDI | Class II | Active |
| Halyard | 79742 | FDA UDI | Class II | Active |
| Halyard | 90113 | FDA UDI | Class II | Active |
| Halyard | 05736 | FDA UDI | Class II | Active |
| Halyard | 44724 | FDA UDI | Class II | Active |
| Halyard | 10023 | FDA UDI | Class I | Active |
| Halyard | 67783 | FDA UDI | Class I | Active |
| Halyard | 47788 | FDA UDI | Class I | Active |
| Halyard | 40697 | FDA UDI | Class II | Active |
| Halyard | 53432 | FDA UDI | Class I | Active |
| Halyard | 04846 | FDA UDI | Class II | Active |
| Halyard | 45269 | FDA UDI | Class I | Active |
| Halyard | 77121 | FDA UDI | Class II | Active |
| Halyard | 67963 | FDA UDI | Class I | Active |
| Halyard | 95331 | FDA UDI | Class II | Active |
| Halyard | 42673 | FDA UDI | Class II | Active |
| Halyard | 89267 | FDA UDI | Class II | Active |
| Halyard | 90003 | FDA UDI | Class II | Active |
| Halyard | 79061 | FDA UDI | Class II | Active |
| Halyard | 77247 | FDA UDI | Class II | Active |
| Halyard | 48971 | FDA UDI | Class II | Active |
| Halyard | 47429 | FDA UDI | Class II | Active |
| Halyard | 02052 | FDA UDI | Class II | Active |
| Halyard | 48297 | FDA UDI | Class II | Active |
| Halyard | 42301 | FDA UDI | Class II | Active |
| Halyard | 49043 | FDA UDI | Class II | Active |
| Halyard | 77903 | FDA UDI | Class II | Active |
| Halyard | 46864 | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (8)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
O&M Halyard, Inc. has eight recall records initiated between September 27, 2021, and April 13, 2026, with statuses recorded as either open or classified. The reasons cited include manufacturing-related issues such as elevated additive residues in sterile packaging, chemical performance failures in nitrile exam gloves, potential sterility compromises in surgical drape packs, noncompliance with bioburden testing for European masks, discoloration and loss of elasticity in gloves over time, filtration efficiency failures in respirators, and mislabeling of surgical caps at the dispenser level.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 13, 2026 | Z-2230-2026 | — | open, classified | Nitrile Exam Glove failed to meet specifications chemical permeation performance. |
| Jul 17, 2025 | Z-2520-2025 | — | open, classified | Surgical drape packs may have open seals, which may compromise the sterility of the product. |
| Nov 26, 2024 | Z-0983-2025 | — | open, classified | Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. |
| Nov 8, 2024 | Z-0729-2025 | — | open, classified | 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. |
| Nov 8, 2024 | Z-0728-2025 | — | open, classified | 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. |
| Feb 20, 2024 | Z-1461-2024 | — | open, classified | Product was mislabeled as a Surgical Cap at its dispenser level. |
| Aug 9, 2023 | Z-2626-2023 | — | open, classified | One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user. |
| Sep 27, 2021 | Z-0317-2022 | — | open, classified | 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. |