Identity
- Trade Name
- ProWorks FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue-Violet, 3 mil, X-Large, 100/bx, 10 bxs/cs FDA UDI
- Model / Reference
- GL-N130FXL FDA UDI
- Description
- ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue-Violet, 3 mil, X-Large, 100/bx, 10 bxs/cs FDA UDI
Identifiers
- Catalog Number
- GL-N130FXL FDA UDI
- Primary DI / UDI-DI
- 00075289130342 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
ProWorks disposable nitrile examination/treatment gloves are a reliable and effective protective barrier for healthcare providers, offering excellent tactile feedback and comfort while maintaining physical properties such as tensile strength and resistance to puncture. Made from durable nitrile materials, these gloves are designed for single-use applications in medical settings.
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Authorization Coverage (1 country)
Regulatory Authorizations
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 b90053c2-6a96-4a93-ba69-0e5d3ef29c6a 35 fields · synced Jul 6, 2026