FDA.reportPublic FDA data

Xguard

Primary DI
08054301890312
Brand
Xguard
Company
EMERSON & CO SRL
Model
RR265
Catalog number
RR265
Device description
Radiation Reducing Glove
Published
2018-03-16
Public version status
New
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
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054301891050PackageGS15In Commercial Distribution
08054301890312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054301891050080543018910508054301891050
08054301890312080543018903128054301890312

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding gloveA personal protective device used to shield the entire hand or hands of an individual (i.e., the operator or other attending person) from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. Each finger is shielded individually. When used in diagnostic x-ray and nuclear medicine, it typically consists of a fluid resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material. The glove offers radiation protection from all directions to the fingers, top and bottom of the hand. Some provide an additional physical barrier protection from liquid radioactive materials and body fluids.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00dry place away from light and heat sources ( below 35° C)

Regulatory Flags#

DUNS number
630558211
Device count
1
Lot or batch
true
Expiration date on label
true
Contains 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
08054301890657FreeguardModel185Model1852018-03-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557940Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557971Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570558008Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557377Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557407Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557438Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557469Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557490Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570536686Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536693Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536709Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536716Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536723Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536730Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12