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HEPRO.US Disposable Nitrile Gloves Class 350 - Size Medium

FDA UDI

Class I (US FDA UDI)

by Hepro.us Inc.

Identity

Trade Name
HEPRO.US Disposable Nitrile Gloves Class 350 - Size Medium FDA UDI
Generic Name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Device Name
Disposable Nitrile Gloves Class 350 - Size Medium Case total 1000 units 10 boxes 100 units per case FDA UDI
Model / Reference
CT - 350 Nitrile Medium FDA UDI
Description
Disposable Nitrile Gloves Class 350 - Size Medium Case total 1000 units 10 boxes 100 units per case FDA UDI

Identifiers

Primary DI / UDI-DI
00850578007983 FDA UDI
FDA Product Code
LZA FDA UDI
GMDN Term
Nitrile 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial

HEPRO.US Disposable Nitrile Gloves Class 350 - Size Medium by Hepro.us Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hepro.us Inc.

Sources (1)

  • FDA UDI 610ce189-7610-4b72-9f1d-a7075b66edeb 33 fields · synced May 31, 2026