FDA.reportPublic FDA data

J2-100

Primary DI
00850020592494
Brand
J2-100
Company
J2 Medical Supply Inc.
Model
JVNGWZ4LC
Device description
BLUE, NITRILE MEDICAL EXAMINATION GLOVES, LATEX-FREE, POWDER-FREE, ASTM D6319
Published
2021-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192333000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192333000Blue Nitrile Examination Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd.2020-01-24LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850020592531PrimaryGS10
00850020592494Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850020592531008500205925318500205925310850020592531
00850020592494008500205924948500205924940850020592494

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-615-8633mariana.pisterman@j2medicalsupply.com

Regulatory Flags#

DUNS number
117257038
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850020592555J2 Medical Supply JVB200SMBJVB200SMB2021-06-04
00850020592562J2 Medical Supply JVB200MDBJVB200MDB2021-06-04
00850020592579J2 Medical Supply JVB200LGBJVB200LGB2021-06-04
00850020592586J2 Medical Supply JVB200XLBJVB200XLB2021-06-04
00850020592890J2 Medical Supply JVB200SMBJVB200SMB2021-06-04
00850020592906J2 Medical Supply JVB200MDBJVB200MDB2021-06-04
00850020592913J2 Medical Supply JVB200LGBJVB200LGB2021-06-04
00850020592920J2 Medical Supply JVB200XLBJVB200XLB2021-06-04
00850020592517J2-100JVNGWZ4SC2021-06-04
00850020592524J2-100JVNGWZ4MC2021-06-04
00850020592531J2-100JVNGWZ4LC2021-06-04
00850020592548J2-100JVNGWZ4XC2021-06-04
00850020592470J2-100JVNGWZ4SC2021-06-04
00850020592487J2-100JVNGWZ4MC2021-06-04
00850020592500J2-100JVNGWZ4XC2021-06-04
00850020592432J-2 100 AdvancedJVBBCHSMC2021-06-04
00850020592449J2-100 AdvancedJVBBCHMDC2021-06-04
00850020592456J2-100 AdvancedJVBBCHLGC2021-06-04
00850020592463J-2 100 AdvancedJVBBCHXLC2021-06-04

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.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
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
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
00810145952122NeuleafMedgluv Inc.LZA2026-06-30
00810145952139NeuleafMedgluv Inc.LZA2026-06-30
00810145952146NeuleafMedgluv Inc.LZA2026-06-30
00810145952108NeuleafMedgluv Inc.LZA2026-06-29
00850005229568NeuflexMedgluv Inc.LZA2026-06-29
00850005229575NeuflexMedgluv Inc.LZA2026-06-29
00850005229582NeuflexMedgluv Inc.LZA2026-06-29
00850005229599NeuflexMedgluv Inc.LZA2026-06-29
00850005229605NeuflexMedgluv Inc.LZA2026-06-29