Identity
- Trade Name
- DISPOSABLE NITRILE GLOVE FDA UDI
- Generic Name
- Nitrile surgical glove, non-powdered FDA UDI
- Model / Reference
- SA-2001NG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809783490303 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Nitrile surgical glove, non-powdered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 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
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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 surgical glove, non-powdered
Disposable Nitrile Glove by Unicoglobal, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- P&P Medical Surgical LLC — P&P Medical Surgical LLC · Class I
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 |
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Manufacturer
- Manufacturer
- Unicoglobal, Inc.
Sources (1)
- FDA UDI b8e6f513-2ac4-4416-b2b5-3ece8fdd1323 32 fields · synced May 30, 2026