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Henry Schein

FDA UDI

Class I (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Henry Schein FDA UDI
Generic Name
Polyisoprene surgical glove, non-powdered, non-antimicrobial FDA UDI
Device Name
Criterion PI Surgical Glove Size 6.5 FDA UDI
Model / Reference
5701121 FDA UDI
Description
Criterion PI Surgical Glove Size 6.5 FDA UDI

Identifiers

Catalog Number
5701121 FDA UDI
Primary DI / UDI-DI
00304040093153 FDA UDI
FDA Product Code
KGO FDA UDI
GMDN Term
Polyisoprene 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Polyisoprene surgical glove, non-powdered, non-antimicrobial

Henry Schein by Henry Schein, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyisoprene surgical glove, non-powdered, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI db53e583-0e97-4a86-a751-e39d196a196a 34 fields · synced Jun 1, 2026