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Biogel® Radiation Protection

FDA UDI

Class I (US FDA UDI)

by Ineo Tech Sdn. Bhd.

Identity

Trade Name
Biogel® Radiation Protection FDA UDI
Generic Name
Radiation attenuating polyisoprene surgical/procedural glove FDA UDI
Device Name
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 2, Size 8.5 FDA UDI
Model / Reference
Model 2 FDA UDI
Description
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 2, Size 8.5 FDA UDI

Identifiers

Catalog Number
53085 FDA UDI
Primary DI / UDI-DI
09551012401510 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

Yes

FDA UDI

Category: Radiation attenuating polyisoprene surgical/procedural glove

Biogel® Radiation Protection by Ineo Tech Sdn. Bhd. — 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
Ineo Tech Sdn. Bhd.

Sources (1)

  • FDA UDI e08eaad5-fda3-487c-8262-888905875fa6 36 fields · synced May 30, 2026