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HEPRO.US Surgical Latex Gloves 7.5"

FDA UDI

Class I (US FDA UDI)

by Hepro.us Inc.

Identity

Trade Name
HEPRO.US Surgical Latex Gloves 7.5" FDA UDI
Generic Name
Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
Device Name
HEPRO.US- Exam Class Latex Gloves Size Medium 7.5" Case 500 pairs total FDA UDI
Model / Reference
CT - Surgical Latex Gloves 7.5" FDA UDI
Description
HEPRO.US- Exam Class Latex Gloves Size Medium 7.5" Case 500 pairs total FDA UDI

Identifiers

Primary DI / UDI-DI
00854427007391 FDA UDI
FDA Product Code
KGO FDA UDI
GMDN Term
Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4460 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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: Hevea-latex surgical glove, non-powdered, non-antimicrobial

HEPRO.US Surgical Latex Gloves 7.5" by Hepro.us Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hevea-latex surgical 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 8f8dc8c6-0e27-49df-b656-14ec5ca9023c 33 fields · synced May 30, 2026