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PrimaPro

FDA UDI

Class I (US FDA UDI)

by Primary Products Company

Identity

Trade Name
PrimaPro FDA UDI
Generic Name
Vinyl examination/treatment glove, non-powdered FDA UDI
Device Name
PrimaPro GentleGuard Vinyl Powder Free Examination Glove Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use FDA UDI
Model / Reference
413-45 FDA UDI
Description
PrimaPro GentleGuard Vinyl Powder Free Examination Glove Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use FDA UDI

Identifiers

Primary DI / UDI-DI
00850022371363 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

No

FDA UDI

Category: Vinyl examination/treatment glove, non-powdered

PrimaPro by Primary Products Company — 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
Primary Products Company

Sources (1)

  • FDA UDI 8508cdfe-9808-42be-858a-79c280fdb6bf 33 fields · synced May 30, 2026