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OmniTrustTM

FDA UDI

Class I (US FDA UDI)

by Omni International Corp.

Identity

Trade Name
OmniTrustTM FDA UDI
Generic Name
Vinyl examination/treatment glove, non-powdered FDA UDI
Device Name
Synethic Vinyl Examination Glove Powder Free Medium FDA UDI
Model / Reference
412-02 FDA UDI
Description
Synethic Vinyl Examination Glove Powder Free Medium FDA UDI

Identifiers

Catalog Number
412-02 FDA UDI
Primary DI / UDI-DI
00810572001387 FDA UDI
FDA Product Code
LYZ FDA UDI
GMDN Term
Vinyl examination/treatment 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: Vinyl examination/treatment glove, non-powdered

OmniTrustTM by Omni International Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Omni International Corp.

Sources (1)

  • FDA UDI ec74921a-ed59-420b-a8d4-7c75eed3ca8e 36 fields · synced Jun 1, 2026