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Ambitex

FDA UDI

Class I (US FDA UDI)

by Tradex Holdings LLC

Identity

Trade Name
AMBITEX FDA UDI
Generic Name
Nitrile examination/treatment glove, non-powdered, sterile FDA UDI
Device Name
0 FDA UDI
Model / Reference
33470-4 FDA UDI
Description
0 FDA UDI

Identifiers

Catalog Number
33470-4 FDA UDI
Primary DI / UDI-DI
00699320334706 FDA UDI
510(k) Number
K113193 FDA UDI
FDA Product Code
LYZ FDA UDI
GMDN Term
Nitrile examination/treatment glove, non-powdered, sterile 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

No

FDA UDI

Category: Nitrile examination/treatment glove, non-powdered, sterile

Ambitex by Tradex Holdings LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nitrile examination/treatment glove, non-powdered, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tradex Holdings LLC

Sources (1)

  • FDA UDI cfb394df-5084-4550-80e2-d58a1140dbed 35 fields · synced May 30, 2026