Identity
- Trade Name
- AMBITEX FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, sterile FDA UDI
- Device Name
- AMBITEX GLV EXAM NON-STERILE VINYL V200 CLEAR POWDER-FREE SMALL SMOOTH STANDARD LENGTH 10/100 FDA UDI
- Model / Reference
- VSM200 FDA UDI
- Description
- AMBITEX GLV EXAM NON-STERILE VINYL V200 CLEAR POWDER-FREE SMALL SMOOTH STANDARD LENGTH 10/100 FDA UDI
Identifiers
- Catalog Number
- VSM200 FDA UDI
- Primary DI / UDI-DI
- 00699320202029 FDA UDI
- FDA Product Code
- LYZ FDA UDI
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, sterile 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
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, sterile
Ambitex by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrile examination/treatment glove, non-powdered, sterile.
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- AMBITEX — Tradex Holdings LLC · Class I
- AMBITEX — Tradex Holdings LLC · Class I
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- KIMTECH STERLING NITRILE STERILE EXAM GLOVES, PAIRS (S) — KIMBERLY-CLARK GLOBAL SALES, INC. · 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
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI ce4c3d4b-02c7-4490-ab2d-28c3d23b408e 34 fields · synced Jun 8, 2026