FDA.reportPublic FDA data

TRADEX INTERNATIONAL

Primary DI
00699320297025
Brand
TRADEX INTERNATIONAL
Company
Tradex International, Inc.
Model
GEN264
Catalog number
GEN264
Device description
Vinyl Exam Clear Powder Free Glove M=5.2g Small
Published
2019-07-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYZVinyl patient examination glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10699320297022PackageGS110Not in Commercial Distribution
00699320297025PrimaryGS10
70699320297024Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1069932029702210699320297022
00699320297025006993202970256993202970250699320297025
7069932029702470699320297024

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
196027981
Device count
100
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00699320102152AMBITEXLXL800LXL8002019-04-22
00699320297032TRADEX INTERNATIONALGEN265GEN2652019-07-23
00699320297049TRADEX INTERNATIONALGEN266GEN2662019-07-23
00699320297056TRADEX INTERNATIONALGEN267GEN2672019-07-23
00699320402627AMBITEXNSM402NSM4022019-04-05
00699320402634AMBITEXNMD402NMD4022019-04-05
00699320402641AMBITEXNLG402NLG4022019-04-05
00699320492222TRADEX INTERNATIONALGEN272GEN2722019-07-23
00699320492239TRADEX INTERNATIONALGEN273GEN2732019-07-23
00699320492246TRADEX INTERNATIONALGEN274GEN2742019-07-23
00699320492253TRADEX INTERNATIONALGEN275GEN2752019-07-23
00699320497227TRADEX INTERNATIONALGEN268GEN2682019-07-23
00699320497234TRADEX INTERNATIONALGEN269GEN2692019-07-23
00699320497241TRADEX INTERNATIONALGEN270GEN2702019-07-23
00699320497258TRADEX INTERNATIONALGEN271GEN2712019-07-23
10699320000073AMBITEXNLG200GNLG200G2021-09-02
10699320000158AMBITEXNMD200GNMD200G2021-09-02
10699320000233AMBITEXNXL200GNXL200G2021-09-02
10699320000196AMBITEXNSM200GNSM200G2021-03-06
10699320102142AMBITEXLLG800LLG8002019-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00713733712835MeijerMEIJER, INC.LYZ2026-06-05
10840330701911ProCureTwin Med, LLCLYZ2026-05-27
10840330701928ProCureTwin Med, LLCLYZ2026-05-27
10840330701935ProCureTwin Med, LLCLYZ2026-05-27
10840330701942ProCureTwin Med, LLCLYZ2026-05-27
10840330701959ProCureTwin Med, LLCLYZ2026-05-27
10840330701966ProCureTwin Med, LLCLYZ2026-05-27
10840330701973ProCureTwin Med, LLCLYZ2026-05-27
10840330701980ProCureTwin Med, LLCLYZ2026-05-27
10840330701997ProCureTwin Med, LLCLYZ2026-05-27
10840330702253ProCureTwin Med, LLCLYZ2026-05-27
10840330702260ProCureTwin Med, LLCLYZ2026-05-27
10840330702277ProCureTwin Med, LLCLYZ2026-05-27
10840330702284ProCureTwin Med, LLCLYZ2026-05-27
10840330705162ProCureTwin Med, LLCLYZ2026-05-27
10840330705179ProCureTwin Med, LLCLYZ2026-05-27
10840330705186ProCureTwin Med, LLCLYZ2026-05-27
10840330705193ProCureTwin Med, LLCLYZ2026-05-27
10840330705209ProCureTwin Med, LLCLYZ2026-05-27
10840330705216ProCureTwin Med, LLCLYZ2026-05-27
10840330705223ProCureTwin Med, LLCLYZ2026-05-27
10840330705230ProCureTwin Med, LLCLYZ2026-05-27
20193489081562MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081586MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081593MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
10889483584446AirLife™AIRLIFELYZ2025-02-14
20197344098184SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-27
20197344098160SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098177SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098191SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26