Identity
- Trade Name
- AuraGuard FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- AuraGuard DDS-N192-20 Size Medium, Nitrile Powder-Free Examination Glove FDA UDI
- Model / Reference
- DDS-N192-20 FDA UDI
- Description
- AuraGuard DDS-N192-20 Size Medium, Nitrile Powder-Free Examination Glove FDA UDI
Identifiers
- Catalog Number
- DDS-N192-20 FDA UDI
- Primary DI / UDI-DI
- 00858711006275 FDA UDI
- FDA Product Code
- LZC FDA UDILZA 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
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
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
AuraGuard by Ansell Healthcare Product — 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
- Ansell Healthcare Product
Sources (1)
- FDA UDI 0fd2b0e8-6d13-44d8-b969-6ba1beba3ed7 35 fields · synced Jun 1, 2026