FDA.reportPublic FDA data

TRADEX INTERNATIONAL

Primary DI
10699320492243
Brand
TRADEX INTERNATIONAL
Company
Cardinal Health 200, LLC
Model
GEN274
Catalog number
GEN274
Device description
Nitrile Exam Blue Powder Free gloves M=4.5g, finger tip Large
Published
2019-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
K081592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081592000POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVESQuality Gallant Sdn. Bhd.2008-12-03LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10699320492243PackageGS110In Commercial Distribution
00699320492246PrimaryGS10
70699320492245Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1069932049224310699320492243
00699320492246006993204922466993204922460699320492246
7069932049224570699320492245

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253005820Monoject8602U8602U2026-11-05
10192253005837Monoject8605U8605U2026-11-05
10192253005844Monoject8607U8607U2026-11-05
10192253005851Monoject8611U8611U2026-11-05
10192253005868Monoject8612U8612U2026-11-05
10192253043112Argyle888830160688883016062026-08-12
10192253043136Argyle888830161488883016142026-08-12
10192253043143Argyle888830162288883016222026-08-12
10192253043181Argyle888830171388883017132026-08-12
10192253043198Argyle888830172188883017212026-08-12
10198956196308CARDINAL HEALTHPO44KLCSDPO44KLCSD2026-11-05
10198956202214CARDINAL HEALTHSBA11BCNMNSBA11BCNMN2026-11-05
10198956270817CARDINAL HEALTHSOP38THBADSOP38THBAD2026-11-05
10198956341296CARDINAL HEALTHSOPDKATCH7SOPDKATCH72026-11-05
10198956346659CARDINAL HEALTHPNV2LMA01CPNV2LMA01C2026-11-05
10198956347021CARDINAL HEALTHSCV5DOVFANSCV5DOVFAN2026-11-05
10198956377486CARDINAL HEALTHSOP42AAJCGSOP42AAJCG2026-11-05
10198956390423CARDINAL HEALTHSOP34ARBCLSOP34ARBCL2026-11-05
10198956391123CARDINAL HEALTHSBAX3FFOHASBAX3FFOHA2026-11-05
10198956391666CARDINAL HEALTHSEY69BPZEBSEY69BPZEB2026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00366975073341BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073358BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073365BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073372BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073389BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
10850061371246American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371260American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371284American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371291American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371307American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371314American Health and SafetyLabsource, Inc.LZA2026-11-02
05060655503450Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503467Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503474Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503481Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655504006Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00755676002529mvetADI MedicalLZA2026-10-23
00755676002550mvetADI MedicalLZA2026-10-23
00755676002581mvetADI MedicalLZA2026-10-23
00755676002611mvetADI MedicalLZA2026-10-23
00755676002765mvetADI MedicalLZA2026-10-23
00755676002796mvetADI MedicalLZA2026-10-23
00755676002826mvetADI MedicalLZA2026-10-23
00755676002857mvetADI MedicalLZA2026-10-23
00755676002994mvetADI MedicalLZA2026-10-23