Identity
- Trade Name
- Safco Nitrilex Black Gloves FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Safco Nitrilex Black powder-free nitrile gloves, (2 small, 2 medium, 2 large), 6 gloves/pack FDA UDI
- Model / Reference
- 5510835 FDA UDI
- Description
- Safco Nitrilex Black powder-free nitrile gloves, (2 small, 2 medium, 2 large), 6 gloves/pack FDA UDI
Identifiers
- Catalog Number
- 5510835 FDA UDI
- Primary DI / UDI-DI
- 10810063754881 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
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
Yes
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, non-antimicrobial
Safco Nitrilex Black Gloves by Safco Dental Supply — 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
- Safco Dental Supply
Sources (1)
- FDA UDI 3b63e9f3-1038-4052-a1d4-af609bbce9c0 34 fields · synced Jun 8, 2026