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PROFENCE Nitrile Powder Free Examination Gloves

FDA UDI

Class I (US FDA UDI)

by Hartalega Ngc Sdn. Bhd.

Identity

Trade Name
PROFENCE Nitrile Powder Free Examination Gloves FDA UDI
Generic Name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Device Name
L - PROFENCE Nitrile Powder Free Examination Gloves FDA UDI
Model / Reference
NITRILE VB35204 FDA UDI
Description
L - PROFENCE Nitrile Powder Free Examination Gloves FDA UDI

Identifiers

Primary DI / UDI-DI
09551007775633 FDA UDI
FDA Product Code
LZA FDA UDI
LZC FDA UDI
QDO 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

PROFENCE Nitrile Powder Free Examination Gloves by Hartalega Ngc Sdn. Bhd. — 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
Hartalega Ngc Sdn. Bhd.

Sources (1)

  • FDA UDI 99c3177c-2829-44d4-b312-0ed6a4f3b899 34 fields · synced May 30, 2026