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Protech Proguard

FDA UDI

Class I (US FDA UDI)

by Emerson & Co Srl

Identity

Trade Name
Protech Proguard FDA UDI
Generic Name
Radiation attenuating polyisoprene surgical/procedural glove FDA UDI
Device Name
Radiation Attenuating Surgical Glove FDA UDI
Model / Reference
FREE165 FDA UDI
Description
Radiation Attenuating Surgical Glove FDA UDI

Identifiers

Catalog Number
FREE165 FDA UDI
Primary DI / UDI-DI
08054301890473 FDA UDI
FDA Product Code
KGO FDA UDI
GMDN Term
Radiation attenuating polyisoprene surgical/procedural glove 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

No

FDA UDI

Category: Radiation attenuating polyisoprene surgical/procedural glove

Protech Proguard by Emerson & Co Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiation attenuating polyisoprene surgical/procedural glove.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Emerson & Co Srl

Sources (1)

  • FDA UDI b3062b24-c3f4-48f4-9456-b4bdd9afa9c6 35 fields · synced May 30, 2026