Identity
- Trade Name
- PureSense FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- PureSense Nitrile Powder-Free, Medium, Nitrile powder-free gloves, Pink in color, Packaging contains recycled material FDA UDI
- Model / Reference
- 1068403 FDA UDI
- Description
- PureSense Nitrile Powder-Free, Medium, Nitrile powder-free gloves, Pink in color, Packaging contains recycled material FDA UDI
Identifiers
- Catalog Number
- 1068403 FDA UDI
- Primary DI / UDI-DI
- D79010684031 FDA UDI
- 510(k) Number
- K212182 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
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
PureSense by Purelife, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212182 also covers:
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
- Purelife, Llc
Sources (1)
- FDA UDI d338c649-a82c-4032-a37b-b040b5683f79 37 fields · synced Jun 6, 2026