Identity
- Trade Name
- Halyard FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- SKYBREEZE* Powder-Free Nitrile Exam Gloves, L FDA UDI
- Model / Reference
- 47376 FDA UDI
- Description
- SKYBREEZE* Powder-Free Nitrile Exam Gloves, L FDA UDI
Identifiers
- Catalog Number
- 47376 FDA UDI
- Primary DI / UDI-DI
- 20680651473763 FDA UDI
- 510(k) Number
- K170136 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Halyard by O&M Halyard, 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.
- VitalGard® Nitrile — Dash Medical Gloves, Inc. · Class I
- Hongray — Grand Work Plastic Products Co., Ltd. · Class I
- Get-A-Grip — SUMMIT GLOVE INC. · Class I
- MARK3 — CARGUS INTERNATIONAL, INC · Class I
- NitriSkin XP — Medgluv Inc. · Class I
- First Aid Only — Acme United Corporation · Class I
- FINISHMASTER — Bunzl USA Holdings LLC · Class I
- Medicom AssureTouch — AMD Medicom Inc · Class I
Cleared under the same submission
K170136 also covers:
- TOUCH Chemo Tested Nitrile Exam Glove — LABOTEK GROUP CORP
- TOUCH Chemo Tested Nitrile Exam Glove — LABOTEK GROUP CORP
- TOUCH Chemo Tested Nitrile Exam Glove — LABOTEK GROUP CORP
- TOUCH Chemo Tested Nitrile Exam Glove — LABOTEK GROUP CORP
- TOUCH Chemo Tested Nitrile Exam Glove — LABOTEK GROUP CORP
- Meijer — MEIJER, INC.
- Meijer — MEIJER, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Wise Choice — Vanguard International Solutions, LLC
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
- O&M Halyard, Inc.
Sources (1)
- FDA UDI ccbd6269-09d6-4709-9023-f6dbfd9e473a 36 fields · synced Jun 8, 2026