FDA.reportPublic FDA data

Biogel® Radiation Protection Micro

Primary DI
19551012401265
Brand
Biogel® Radiation Protection Micro
Company
INEO TECH SDN. BHD.
Model
Model 1
Catalog number
52080
Device description
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 1, Size 8
Published
2025-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
19551012401265PackageGS11In Commercial Distribution
29551012401347PackageGS15In Commercial Distribution
39551012401429PackageGS120In Commercial Distribution
09551012401183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1955101240126519551012401265
2955101240134729551012401347
3955101240142939551012401429
09551012401183095510124011839551012401183

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
659311031
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

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