FDA.reportPublic FDA data

Merit Black Ntrile Examination Gloes Powder Free

Primary DI
00072288164484
Brand
Merit Black Ntrile Examination Gloes Powder Free
Company
Amercareroyal, LLC
Model
ME-5050-XL
Published
2023-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical 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
00072288164347PackageGS110In Commercial Distribution
00072288164484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00072288164347000722881643470722881643470072288164347
00072288164484000722881644840722881644840072288164484

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.

Regulatory Flags#

DUNS number
002326965
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00072288164415Merit Blue Ntrile Examination Gloes Powder FreeME-5025-L2023-10-25
00072288164422Merit Blue Ntrile Examination Gloes Powder FreeME-5025-M2023-10-25
00072288164439Merit Blue Ntrile Examination Gloes Powder FreeME-5025-S2023-10-25
00072288164453Merit Black Ntrile Examination Gloes Powder FreeME-5050-L2023-10-25
00072288164460Merit Black Ntrile Examination Gloes Powder FreeME-5050-M2023-10-25
00072288164477Merit Black Ntrile Examination Gloes Powder FreeME-5050-S2023-10-25
00072288164279Merit Blue Ntrile Examination Gloes Powder FreeME-5025-L2023-10-25
00072288164286Merit Blue Ntrile Examination Gloes Powder FreeME-5025-M2023-10-25
00072288164293Merit Blue Ntrile Examination Gloes Powder FreeME-5025-S2023-10-25
00072288164446Merit Blue Ntrile Examination Gloes Powder FreeME-5025-XL2023-10-25
00072288164316Merit Black Ntrile Examination Gloes Powder FreeME-5050-L2023-10-25
00072288164323Merit Black Ntrile Examination Gloes Powder FreeME-5050-M2023-10-25
00072288164330Merit Black Ntrile Examination Gloes Powder FreeME-5050-S2023-10-25
00072288164347Merit Black Ntrile Examination Gloes Powder FreeME-5050-XL2023-10-25
00072288164521AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves432022023-10-08
00072288164545AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves432032023-10-08
00072288164569AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves432042023-10-08
00072288164583AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves432052023-10-08
00072288164507AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves432012023-10-08
00072288164514AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves432022023-10-08

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