Biogel® Radiation Protection

Basic Information

• Brand Name: Biogel® Radiation Protection
• Primary DI: 09551012401510
• Version / Model: Model 2
• Catalog Number: 53085
• Company Name: INEO TECH SDN. BHD.
• Labeler DUNS: 659311031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-09
• Public Version: 3
• Public Version Date: 2026-01-16
• Public Version Status: Update
• Public Device Record Key: e08eaad5-fda3-487c-8262-888905875fa6

Device Description

Radiation Attenuating Surgical Gloves, Polyisoprene, Powder Free, Model 2M, Size 8.5

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGO	Surgeon'S Gloves	General, Plastic Surgery	878.4460	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59062	Radiation attenuating polyisoprene surgical/procedural glove	A sterile device made of polyisoprene intended as a protective barrier when worn on the hands of healthcare providers at the surgical/procedural site; its inner surface is not powdered and the glove's material matrix contains radiation attenuating material intended to limit exposure to incident radiation (e.g., during fluoroscopy). It is used mainly as a two-way barrier to protect patient and staff from contaminants. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, elasticity) and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	19551012401593	GS1	POUCH	1	In Commercial Distribution
Primary	09551012401510	GS1
Package	29551012401675	GS1	DISPENSING BOX	5	In Commercial Distribution
Package	39551012401757	GS1	SHIPPING CARTON	20	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8.5

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius