Identity
- Trade Name
- Nephron Nitrile FDA UDI
- Generic Name
- Nitrile surgical glove, non-powdered FDA UDI
- Device Name
- Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) MD FDA UDI
- Model / Reference
- 200203003 FDA UDI
- Description
- Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) MD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850045437930 FDA UDI
- 510(k) Number
- K232654 FDA UDI
- FDA Product Code
- LZA FDA UDILZC FDA UDIOPJ FDA UDIQDO FDA UDI
- GMDN Term
- Nitrile surgical glove, non-powdered 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 surgical glove, non-powdered
Nephron Nitrile by Nephron Nitrile LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Nitrile surgical glove, non-powdered.
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- FifthPulse — Jeg & Sons Inc. · Class I
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Cleared under the same submission
K232654 also covers:
- Black Talon — NORTH AMERICAN RESCUE, LLC.
- Black Talon — NORTH AMERICAN RESCUE, LLC.
- Black Talon — NORTH AMERICAN RESCUE, LLC.
- Black Talon — NORTH AMERICAN RESCUE, LLC.
- Black Talon — NORTH AMERICAN RESCUE, LLC.
- Black Talon — NORTH AMERICAN RESCUE, LLC.
- Nephron Nitrile — Nephron Nitrile LLC
- Nephron Nitrile — Nephron Nitrile LLC
- Nephron Nitrile — Nephron Nitrile LLC
- Nephron Nitrile — Nephron Nitrile LLC
- Nephron Nitrile — Nephron Nitrile LLC
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
- Nephron Nitrile LLC
Sources (1)
- FDA UDI 2dced974-df77-4cc9-af68-c5a02273ca5c 34 fields · synced May 30, 2026