FDA.reportPublic FDA data

Josen

Primary DI
00850042242599
Brand
Josen
Company
Sino City USA LLC
Model
NME1234J
Published
2024-04-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
K210691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210691000Disposable Nitrile Medical Examination GloveJiangsu Cureguard Glove Co., Ltd.2021-07-30LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850042242596PackageGS110Not in Commercial Distribution
00850042242599PrimaryGS10
85004224259900Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004224259610850042242596
00850042242599008500422425998500422425990850042242599
8500422425990085004224259900

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
118715921
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
00850042242285JosenNME1332J2024-04-20
00850042242292JosenNME1333J2024-04-20
00850042242308JosenNME1334J2024-04-20
00850042242315JosenNME1335J2024-04-20
00850042242582JosenNME1235J2024-04-30
00850042242605JosenNME1233J2024-04-30
00850042242612JosenNME1232J2024-04-30
00850042242629JosenNME1231J2024-04-30
00850042242278JosenNME1331J2024-04-20
00850042242049JosenDisposable Vinyl Examination M5.0-S (100 pcs)2022-12-06
00850042242056JosenDisposable Vinyl Examination M5.0-M (100 pcs)2022-12-06
00850042242063JosenDisposable Vinyl Examination M5.0-L (100 pcs)2022-12-06
00850042242070JosenDisposable Vinyl Examination M5.0-XL (100pcs)2022-12-06
00850042242131JosenDisposable Vinyl Synthetic Gloves Blue M5.0-S (1002022-12-06
00850042242148JosenDisposable Vinyl Synthetic Gloves Blue M5.0-M (1002022-12-06
00850042242155JosenDisposable Vinyl Synthetic Gloves Blue M5.0-L (1002022-12-06
00850042242162JosenDisposable Vinyl Synthetic Gloves Blue M5.0-XL (102022-12-06
00850042242179JosenDisposable Vinyl Synthetic Gloves Black M5.0-XL (12022-12-06
00850042242186JosenDisposable Vinyl Synthetic Gloves Black M5.0-L (102022-12-06
00850042242193JosenDisposable Vinyl Synthetic Gloves Black M5.0-M (102022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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