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Gloves

FDA UDI

Class I (US FDA UDI)

by Geri-Gentle Corporation

Identity

Trade Name
Gloves FDA UDI
Generic Name
Vinyl examination/treatment glove, non-powdered FDA UDI
Device Name
GLOVES VINYL PF N/S LG FDA UDI
Model / Reference
12291 FDA UDI
Description
GLOVES VINYL PF N/S LG FDA UDI

Identifiers

Primary DI / UDI-DI
00369771001389 FDA UDI
510(k) Number
K093270 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

No

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

Gloves by Geri-Gentle Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K093270 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Geri-Gentle Corporation

Sources (1)

  • FDA UDI 5893098b-0514-40b5-a59e-64856ae6a3ef 34 fields · synced May 30, 2026