Identity
- Trade Name
- Enov-8 FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- ENOV-8 Disposable Nitrile Exam Grade Gloves, Powder Free, CHEM-FEN-DERM BLUE 2.5MIL 10/200–L FDA UDI
- Model / Reference
- GL-NCF225BFL FDA UDI
- Description
- ENOV-8 Disposable Nitrile Exam Grade Gloves, Powder Free, CHEM-FEN-DERM BLUE 2.5MIL 10/200–L FDA UDI
Identifiers
- Catalog Number
- GL-NCF225BFL FDA UDI
- Primary DI / UDI-DI
- 00075289122521 FDA UDI
- FDA Product Code
- LZA 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
Yes
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
No
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
Enov-8 by Tranzonic Acquisition Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Tranzonic Acquisition Corp.
Sources (1)
- FDA UDI 7472a8e9-c67e-4f3d-88d8-0eb8c755fe24 35 fields · synced Jun 1, 2026