Identity
- Trade Name
- Halyard FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- STERLING* NITRILE-XTRA* Powder-Free PPE Exam Gloves, L (CE) FDA UDI
- Model / Reference
- 44289 FDA UDI
- Description
- STERLING* NITRILE-XTRA* Powder-Free PPE Exam Gloves, L (CE) FDA UDI
Identifiers
- Catalog Number
- 44289 FDA UDI
- Primary DI / UDI-DI
- 20680651442899 FDA UDI
- 510(k) Number
- K081089 FDA UDI
- FDA Product Code
- LZC FDA UDI
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Halyard by Avanos Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrile examination/treatment glove, non-powdered, non-antimicrobial.
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- NitriSkin XP — Medgluv Inc. · Class I
- First Aid Only — Acme United Corporation · Class I
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Cleared under the same submission
K081089 also covers:
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 5677c0de-65f8-4614-bb6f-cce4b5b990bd 36 fields · synced Jun 9, 2026