Identity
- Trade Name
- FLEXAL FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Nitrile Exam Gloves Flexal FDA UDI
- Model / Reference
- 88TN01XS FDA UDI
- Description
- Nitrile Exam Gloves Flexal FDA UDI
Identifiers
- Catalog Number
- 88TN01XS FDA UDI
- Primary DI / UDI-DI
- 20885380137102 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
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
FLEXAL is a premium nitrile examination/treatment glove designed for healthcare providers, providing a reliable barrier against patient contaminants and risk of allergy to latex. With its unique non-powdered, non-antimicrobial design, FLEXAL ensures comfort and tactility during medical procedures.
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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
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI 0820e705-710d-4388-92d0-68bff5f32e95 34 fields · synced Oct 6, 2026