FDA.reportPublic FDA data

J2 Medical Supply

Primary DI
00850020592906
Brand
J2 Medical Supply
Company
J2 Medical Supply Inc.
Model
JVB200MDB
Catalog number
JVB200MDB
Device description
J2-100 Advance Nitrile Gloves (200ct)
Published
2021-06-04
Public version status
Update
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
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170136000Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Feiyang Professional Gloves Co., Ltd.2017-08-25LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850020592951PackageGS110In Commercial Distribution
00850020592562PrimaryGS10
00850020592906Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850020592951008500205929518500205929510850020592951
00850020592562008500205925628500205925620850020592562
00850020592906008500205929068500205929060850020592906

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
8556158633khristina.kleintop@j2medicalsupply.com

Regulatory Flags#

DUNS number
117257038
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZC2026-06-04
09001570557278Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557940Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557971Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570558008Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557377Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12