FDA.reportPublic FDA data

Xguard

Primary DI
08054301890305
Brand
Xguard
Company
EMERSON & CO SRL
Model
RR260
Catalog number
RR260
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
08054301891043PackageGS15In Commercial Distribution
08054301890305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054301891043080543018910438054301891043
08054301890305080543018903058054301890305

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
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZC2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZC2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZC2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZC2026-07-14
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LULINE, INC.LZC2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MULINE, INC.LZC2026-07-10
10850015055932EXT CUFF 12 MIL LATEX GLOVES-SULINE, INC.LZC2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XULINE, INC.LZC2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810145952429NitraGrip Pro 100Medgluv Inc.LZC2026-06-30
00810145952436NitraGrip Pro 100Medgluv Inc.LZC2026-06-30
00810145952443NitraGrip Pro 100Medgluv Inc.LZC2026-06-30
00810145952450NitraGrip Pro 100Medgluv Inc.LZC2026-06-30
00810145952467NitraGrip Pro 100Medgluv Inc.LZC2026-06-30
00850069531256AnthemMaxter Healthcare IncorporatedLZC2026-06-28
00850069531263AnthemMaxter Healthcare IncorporatedLZC2026-06-28
00850069531270AnthemMaxter Healthcare IncorporatedLZC2026-06-28
00850069531287AnthemMaxter Healthcare IncorporatedLZC2026-06-28
00850069531294AnthemMaxter Healthcare IncorporatedLZC2026-06-28
00850069531300AnthemMaxter Healthcare IncorporatedLZC2026-06-28
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04