FDA.reportPublic FDA data

AuraGuard

Primary DI
00858711006305
Brand
AuraGuard
Company
Ansell Healthcare Product
Model
DDS-N193-20
Catalog number
DDS-N193-20
Device description
AuraGuard DDS-N193-20 Size Large, Nitrile Powder-Free Examination Glove
Published
2022-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858711006299PackageGS110In Commercial Distribution
00858711006305PrimaryGS10
00858711006077Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858711006299008587110062998587110062990858711006299
00858711006305008587110063058587110063050858711006305
00858711006077008587110060778587110060770858711006077

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
775-470-7106don.cronk@ansell.com
775-746-6600jacob.ramirez@ansell.com

Regulatory Flags#

DUNS number
111267330
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00769799205019MICROFLEXEV-2050-XSEV-2050-XS2022-03-17
00769799205026MICROFLEXEV-2050-SEV-2050-S2022-03-17
00769799205033MICROFLEXEV-2050-MEV-2050-M2022-03-17
00769799205040MICROFLEXEV-2050-LEV-2050-L2022-03-17
00769799205057MICROFLEXEV-2050-XLEV-2050-XL2022-03-17
10076490788657MICROFLEXXC-310CP-XSXC-310CP-XS2025-08-05
10076490788664MICROFLEX XC-310CP-SXC-310CP-S2025-08-05
10076490788671MICROFLEXXC-310CP-MXC-310CP-M2025-08-05
10076490788688MICROFLEXXC-310CP-LXC-310CP-L2025-08-05
10076490788695MICROFLEXXC-310CP-XLXC-310CP-XL2025-08-05
20076490793160MICROFLEXXC-310CP-XSXC-310CP-XS2025-08-05
20076490793177MICROFLEX XC-310CP-SXC-310CP-S2025-08-05
20076490793184MICROFLEXXC-310CP-MXC-310CP-M2025-08-05
20076490793191MICROFLEXXC-310CP-LXC-310CP-L2025-08-05
20076490793207MICROFLEXXC-310CP-XLXC-310CP-XL2025-08-05
10076490456525TOUCHNTUFF69318070693180702025-07-30
10076490456532TOUCHNTUFF69318080693180802025-07-30
10076490456549TOUCHNTUFF69318090693180902025-07-30
10076490456556TOUCHNTUFF69318100693181002025-07-30
10076490456518TOUCHNTUFF69318060693180602025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZC2026-07-14
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZC2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZC2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZC2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
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
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06