FDA.reportPublic FDA data

Biogel® Radiation Protection Micro

Primary DI
09551012401923
Brand
Biogel® Radiation Protection Micro
Company
INEO TECH SDN. BHD.
Model
Model 1
Catalog number
52090
Device description
Radiation Attenuating Surgical Gloves, Polyisoprene, Powder Free, Model 1M, Size 9
Published
2025-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19551012401845PackageGS11In Commercial Distribution
29551012401361PackageGS15In Commercial Distribution
39551012401443PackageGS120In Commercial Distribution
09551012401923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1955101240184519551012401845
2955101240136129551012401361
3955101240144339551012401443
09551012401923095510124019239551012401923

GMDN Terms#

Term, Definition table
TermDefinition
Radiation attenuating polyisoprene surgical/procedural gloveA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
659311031
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09551012401459Biogel® Radiation ProtectionModel 2530552025-09-09
09551012401466Biogel® Radiation ProtectionModel 2530602025-09-09
09551012401473Biogel® Radiation ProtectionModel 2530652025-09-09
09551012401480Biogel® Radiation ProtectionModel 2530702025-09-09
09551012401497Biogel® Radiation ProtectionModel 2530752025-09-09
09551012401503Biogel® Radiation ProtectionModel 2530802025-09-09
09551012401510Biogel® Radiation ProtectionModel 2530852025-09-09
09551012401527Biogel® Radiation ProtectionModel 2530902025-09-09
09551012401862Biogel® Radiation Protection MicroModel 1520602025-09-09
09551012401879Biogel® Radiation Protection MicroModel 1520652025-09-09
09551012401886Biogel® Radiation Protection MicroModel 1520702025-09-09
09551012401893Biogel® Radiation Protection MicroModel 1520752025-09-09
09551012401909Biogel® Radiation Protection MicroModel 1520802025-09-09
09551012401916Biogel® Radiation Protection MicroModel 1520852025-09-09
09551012401855Biogel® Radiation Protection MicroModel 1520552025-09-09
19551012401784Biogel® Radiation Protection MicroModel 1520602025-09-09
19551012401791Biogel® Radiation Protection MicroModel 1520652025-09-09
19551012401807Biogel® Radiation Protection MicroModel 1520702025-09-09
19551012401814Biogel® Radiation Protection MicroModel 1520752025-09-09
19551012401821Biogel® Radiation Protection MicroModel 1520802025-09-09

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