FDA.reportPublic FDA data

Biogel® Radiation Protection Micro

Primary DI
09551012401879
Brand
Biogel® Radiation Protection Micro
Company
INEO TECH SDN. BHD.
Model
Model 1
Catalog number
52065
Device description
Radiation Attenuating Surgical Gloves, Polyisoprene, Powder Free, Model 1M, Size 6.5
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
19551012401791PackageGS11In Commercial Distribution
29551012401316PackageGS15In Commercial Distribution
39551012401399PackageGS120In Commercial Distribution
09551012401879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1955101240179119551012401791
2955101240131629551012401316
3955101240139939551012401399
09551012401879095510124018799551012401879

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
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
09551012401923Biogel® Radiation Protection MicroModel 1520902025-09-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09001570557278Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557940Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557971Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570558008Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557285Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557377Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557407Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557438Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557469Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557490Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570536686Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536693Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536709Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536716Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536723Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536730Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12