FDA.reportPublic FDA data

J2-100

Primary DI
00850020592548
Brand
J2-100
Company
J2 Medical Supply Inc.
Model
JVNGWZ4XC
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
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
00850020592548PrimaryGS10
00850020592500Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850020592548008500205925488500205925480850020592548
00850020592500008500205925008500205925000850020592500

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
855-615-8633mariana.pisterman@j2medicalsupply.com

Regulatory Flags#

DUNS number
117257038
Device count
100
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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
00850020592470J2-100JVNGWZ4SC2021-06-04
00850020592487J2-100JVNGWZ4MC2021-06-04
00850020592494J2-100JVNGWZ4LC2021-06-04
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

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00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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