FDA.reportPublic FDA data

Josen

Primary DI
10850042242312
Brand
Josen
Company
Sino City USA LLC
Model
NME1335J
Published
2024-04-20
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

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850042242312PackageGS110In Commercial Distribution
00850042242315PrimaryGS10
85004224231500Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004224231210850042242312
00850042242315008500422423158500422423150850042242315
8500422423150085004224231500

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

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
00850042242599JosenNME1234J2024-04-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01