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Next Generation Stretch Vinyl Exam Gloves

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name
Next Generation Stretch Vinyl Exam Gloves FDA UDI
Generic Name
Ethylene vinyl acetate examination/treatment glove, non-powdered FDA UDI
Device Name
Next Generation Stretch Vinyl Exam Gloves, Powder-Free, Medium FDA UDI
Model / Reference
6823 FDA UDI
Description
Next Generation Stretch Vinyl Exam Gloves, Powder-Free, Medium FDA UDI

Identifiers

Primary DI / UDI-DI
00709553682328 FDA UDI
510(k) Number
K100486 FDA UDI
FDA Product Code
LYZ FDA UDI
GMDN Term
Ethylene vinyl acetate 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Ethylene vinyl acetate examination/treatment glove, non-powdered

Next Generation Stretch Vinyl Exam Gloves by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ethylene vinyl acetate examination/treatment glove, non-powdered.

Cleared under the same submission

K100486 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dynarex Corp.

Sources (1)

  • FDA UDI 88da8f01-7ce7-47c3-9895-2ed9d7ab5713 34 fields · synced May 31, 2026