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Black Talon

FDA UDI

Class I (US FDA UDI)

by North American Rescue, Llc.

Identity

Trade Name
Black Talon FDA UDI
Generic Name
Nitrile surgical glove, non-powdered FDA UDI
Device Name
GLOVES, BLACK NITRILE - SMALL (Box of 100) FDA UDI
Model / Reference
70-0001 FDA UDI
Description
GLOVES, BLACK NITRILE - SMALL (Box of 100) FDA UDI

Identifiers

Catalog Number
70-0001 FDA UDI
Primary DI / UDI-DI
00842209133277 FDA UDI
510(k) Number
K232654 FDA UDI
FDA Product Code
LZA FDA UDI
LZC FDA UDI
OPJ FDA UDI
QDO 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.

Cleared under the same submission

K232654 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
North American Rescue, Llc.

Sources (1)

  • FDA UDI f109fa3a-b031-4cbc-94ba-e5eaac91eb05 35 fields · synced Jun 8, 2026