Biogel® Radiation Protection 53080

GUDID 19551012401586

PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 2, Size 8

INEO TECH SDN. BHD.

Radiation attenuating polyisoprene surgical/procedural glove

• Primary Device ID: 19551012401586
• NIH Device Record Key: af9c3088-7850-467c-9926-d07a0f2624ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biogel® Radiation Protection
• Version Model Number: Model 2
• Catalog Number: 53080
• Company DUNS: 659311031
• Company Name: INEO TECH SDN. BHD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09551012401503 [Primary]
GS1	19551012401586 [Package]; Contains: 09551012401503; Package: POUCH [1 Units]; In Commercial Distribution
GS1	29551012401668 [Package]; Package: DISPENSING BOX [5 Units]; In Commercial Distribution
GS1	39551012401740 [Package]; Contains: 29551012401668; Package: SHIPPING CARTON [20 Units]; In Commercial Distribution

FDA Product Code

• KGO: Surgeon'S Gloves

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-17
• Device Publish Date: 2025-09-09

On-Brand Devices [Biogel® Radiation Protection]

• 19551012401609: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 2, Size 9
• 19551012401593: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 2, Size 8.5
• 19551012401586: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 2, Size 8
• 19551012401579: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 2, Size 7.5
• 19551012401562: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 2, Size 7
• 19551012401555: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 2, Size 6.5
• 19551012401548: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 2, Size 6
• 19551012401531: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 2, Size 5.5