Identity
- Trade Name
- Critigear FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, sterile FDA UDI
- Model / Reference
- HCGS0022 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810012921036 FDA UDI
- FDA Product Code
- LZA FDA UDILZC 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, sterile
Critigear by Contec, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrile examination/treatment glove, non-powdered, sterile.
- KIMTECH PURPLE NITRILE EXAM GLOVES, STERILE PAIRS (M) — KIMBERLY-CLARK GLOBAL SALES, INC. · Class I
- KIMTECH STERLING NITRILE STERILE EXAM GLOVES, PAIRS (M) — KIMBERLY-CLARK GLOBAL SALES, INC. · Class I
- AMBITEX — Cardinal Health 200, LLC · Class I
- ChemoPlus — Cardinalhealth · Class I
- AMBITEX — Tradex Holdings LLC · Class I
- AMBITEX — Cardinal Health 200, LLC · Class I
- AMBITEX — Tradex Holdings LLC · Class I
- AMBITEX — Cardinal Health 200, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Contec, Inc.
Sources (1)
- FDA UDI a72fc11d-7a57-4ce8-99a9-893d5817fa0f 32 fields · synced May 30, 2026