FDA.reportPublic FDA data

Josen

Primary DI
00850042242087
Brand
Josen
Company
Sino City USA LLC
Model
Disposable Nitrile Examination Gloves Blue M3.5-XS
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K110981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110981000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850042242084PackageGS110In Commercial Distribution
00850042242087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004224208410850042242084
00850042242087008500422420878500422420870850042242087

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
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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

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Primary DI, Brand, Company table
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