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Dura-Cor

FDA UDI

Class I (US FDA UDI)

by International Sourcing Company, Inc.

Identity

Trade Name
DURA-COR FDA UDI
Generic Name
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Device Name
EXAMINATION GLOVES LATEX POWDER FREE FDA UDI
Model / Reference
4030M FDA UDI
Description
EXAMINATION GLOVES LATEX POWDER FREE FDA UDI

Identifiers

Catalog Number
4030M FDA UDI
Primary DI / UDI-DI
00796326000939 FDA UDI
510(k) Number
K192329 FDA UDI
FDA Product Code
LYY FDA UDI
GMDN Term
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Dura-Cor by International Sourcing Company, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial.

Cleared under the same submission

K192329 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
International Sourcing Company, Inc.

Sources (1)

  • FDA UDI 0f54860b-9834-453c-be25-a0657f4b5523 38 fields · synced Jun 1, 2026