Identity
- Trade Name
- DOMREX™ PI GLOVES FDA UDI
- Generic Name
- Polyisoprene surgical glove, non-powdered, non-antimicrobial FDA UDI
- Model / Reference
- 70 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628032222704 FDA UDI
- FDA Product Code
- OPJ FDA UDI
- GMDN Term
- Polyisoprene surgical 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
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
No
FDA UDI
Category: Polyisoprene surgical glove, non-powdered, non-antimicrobial
Domrex™ Pi Gloves by Domrex Pharma Inc — 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
- Domrex Pharma Inc
Sources (1)
- FDA UDI 09da2cb2-758f-423d-9569-1d89eb4e5305 32 fields · synced May 30, 2026