FDA.reportPublic FDA data

Freeguard

Primary DI
08054301890657
Brand
Freeguard
Company
EMERSON & CO SRL
Model
Model185
Catalog number
Model185
Device description
Radiation Attenuating Surgical Glove
Published
2018-03-16
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
08054301891395PackageGS15In Commercial Distribution
08054301890657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054301891395080543018913958054301891395
08054301890657080543018906578054301890657

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
Circumference8.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00dry place away from light and heat sources

Regulatory Flags#

DUNS number
630558211
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054301890602FreeguardModel160Model1602018-03-16
08054301890619FreeguardModel165Model1652018-03-16
08054301890626FreeguardModel170Model1702018-03-16
08054301890633FreeguardModel175Model1752018-03-16
08054301890640FreeguardModel180Model1802018-03-16
08054301890664FreeguardModel190Model1902018-03-16
08054301890671FreeguardModel260Model2602018-03-16
08054301890688FreeguardModel265Model2652018-03-16
08054301890695FreeguardModel270Model2702018-03-16
08054301890701FreeguardModel275Model2752018-03-16
08054301890718FreeguardModel280Model2802018-03-16
08054301890725FreeguardModel285Model2852018-03-16
08054301890732FreeguardModel290Model2902018-03-16
08054301891500FreeguardModel170Model1702021-01-26
08054301891517FreeguardModel175Model1752021-01-26
08054301891531FreeguardModel185Model1852021-01-28
08054301891548FreeguardModel190Model1902021-01-28
08054301891555FreeguardModel260Model2602021-01-28
08054301891562FreeguardModel265Model2652021-01-28
08054301891579FreeguardModel270Model2702021-01-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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