FDA.reportPublic FDA data

NitraCare Aloe

Primary DI
00893257001025
Brand
NitraCare Aloe
Company
Medgluv Inc.
Model
MG5053A
Catalog number
MG5053A
Device description
NitraCare Nitrile Aloe Exam Gloves, Green, Large
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer patient examination glove
LZCMedical Glove, Specialty
QDOFentanyl and other opioid protection glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00893257001520PackageGS110In Commercial Distribution
00893257001025PrimaryGS10
00810145950777Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00893257001520008932570015208932570015200893257001520
00893257001025008932570010258932570010250893257001025
00810145950777008101459507778101459507770810145950777

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
+1(866)633-4588sales@medgluv.com

Regulatory Flags#

DUNS number
015809044
Device count
200
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810145950975NeuMask PinkMGM103MGM1032026-07-17
00850005229728NeuMask OrangeMGM102MGM1022026-07-17
00850005229803NeulynxMG57500MG575002026-07-17
00850005229810NeulynxMG57501MG575012026-07-17
00850005229827NeulynxMG57502MG575022026-07-17
00850005229834NeulynxMG57503MG575032026-07-17
00850005229841NeulynxMG57504MG575042026-07-17
00810145952054NeuSkin ClearMG3000MG30002026-06-29
00810145952061NeuSkin ClearMG3001MG30012026-06-29
00810145952078NeuSkin ClearMG3002MG30022026-06-29
00810145952085NeuSkin ClearMG3003MG30032026-06-29
00810145952092NeuSkin ClearMG3004MG30042026-06-29
00810145952108NeuleafMG57700MG577002026-06-29
00810145952115NeuleafMG57701MG577012026-06-30
00810145952122NeuleafMG57702MG577022026-06-30
00810145952139NeuleafMG57703MG577032026-06-30
00810145952146NeuleafMG57704MG577042026-06-30
00810145952429NitraGrip Pro 100MG5009XP1MG5009XP12026-06-30
00810145952436NitraGrip Pro 100MG5009XP2MG5009XP22026-06-30
00810145952443NitraGrip Pro 100MG5009XP3MG5009XP32026-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850005229803NeulynxMedgluv Inc.QDO2026-07-17
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.QDO2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.QDO2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.QDO2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.QDO2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.QDO2026-07-14
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZC2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZC2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.QDO2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.QDO2026-07-14
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.QDO2026-07-14
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