Identity
- Trade Name
- Black Talon FDA UDI
- Generic Name
- Nitrile surgical glove, non-powdered FDA UDI
- Device Name
- GLOVES, BLACK NITRILE - SMALL (1000 pack) FDA UDI
- Model / Reference
- ZZ-0274 FDA UDI
- Description
- GLOVES, BLACK NITRILE - SMALL (1000 pack) FDA UDI
Identifiers
- Catalog Number
- ZZ-0274 FDA UDI
- Primary DI / UDI-DI
- 40842209133275 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
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 surgical glove, non-powdered
Black Talon by North American Rescue, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrile surgical glove, non-powdered.
- CORRECT TOUCH — Ct International · Class I
- CORRECT TOUCH — Ct International · Class I
- FifthPulse — Jeg & Sons Inc. · Class I
- FifthPulse — Jeg & Sons Inc. · Class I
- FifthPulse — Jeg & Sons Inc. · Class I
- CORRECT TOUCH — Ct International · Class I
- Nephron Nitrile — Nephron Nitrile LLC · Class I
- P&P Medical Surgical LLC — P&P Medical Surgical LLC · Class I
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.
- 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
- 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
- North American Rescue, Llc.
Sources (1)
- FDA UDI 45916801-f73f-4702-ba43-f93a5b9bbb1c 35 fields · synced May 31, 2026