FDA.reportPublic FDA data

TRADEX INTERNATIONAL

Primary DI
00699320492253
Brand
TRADEX INTERNATIONAL
Company
Tradex International, Inc.
Model
GEN275
Catalog number
GEN275
Device description
Nitrile Exam Blue Powder Free gloves M 4.5g, finger tip XL
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
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
10699320492250PackageGS110Not in Commercial Distribution
00699320492253PrimaryGS10
70699320492252Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1069932049225010699320492250
00699320492253006993204922536993204922530699320492253
7069932049225270699320492252

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
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
00699320297025TRADEX INTERNATIONALGEN264GEN2642019-07-23
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
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
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
10840330702246ProCureTwin Med, LLCLZA2026-06-01
10840330706756ProCureTwin Med, LLCLZA2026-06-01
10840330706763ProCureTwin Med, LLCLZA2026-06-01
10840330706770ProCureTwin Med, LLCLZA2026-06-01
10840330706787ProCureTwin Med, LLCLZA2026-06-01