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StarMed Ultra/Tender Touch Nitrile Exam Glove

FDA UDI

Class I (US FDA UDI)

by Sempermed Usa, Inc.

Identity

Trade Name
StarMed Ultra/Tender Touch Nitrile Exam Glove FDA UDI
Generic Name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Device Name
StarMed Ultra/Tender Touch Nitrile Exam Glove, sample pack FDA UDI
Model / Reference
SPK-035VB FDA UDI
Description
StarMed Ultra/Tender Touch Nitrile Exam Glove, sample pack FDA UDI

Identifiers

Catalog Number
SPK-035VB FDA UDI
Primary DI / UDI-DI
00841277107173 FDA UDI
FDA Product Code
LZA FDA UDI
OPJ 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

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

StarMed Ultra/Tender Touch Nitrile Exam Glove by Sempermed Usa, 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
Sempermed Usa, Inc.

Sources (1)

  • FDA UDI 83381616-5fa1-4298-a64c-75ea08d3acb8 35 fields · synced May 30, 2026