FDA.reportPublic FDA data

ProWorks

Primary DI
10075289145077
Brand
ProWorks
Company
TRANZONIC COMPANIES, THE
Model
GL-N107FM
Catalog number
GL-N107FM
Device description
ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 6 mil, Medium, 100/bx, 10 bxs/cs
Published
2020-04-02
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

Contact Domains#

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
K151528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151528000Powder Free Nitrile (Black) Examination GlovesGallant Quality Sdn. Bhd.2015-10-09LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10075289145077PackageGS110In Commercial Distribution
00075289145070PrimaryGS10
70075289145079Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007528914507710075289145077
00075289145070000752891450700752891450700075289145070
7007528914507970075289145079

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8003219832info@hospeco.com

Regulatory Flags#

DUNS number
007900020
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00075289522178ISO-MEDISOEVA100ISOEVA1002026-06-22
00075289522185ISO-MEDISOEVA1000ISOEVA10002026-06-22
00075289522192ISO-MEDISOEVA150ISOEVA1502026-06-22
00075289522208ISO-MEDISOEVA2000ISOEVA20002026-06-22
00075289522215ISO-MEDISOEVA250ISOEVA2502026-06-22
00075289522222ISO-MEDISOEVA3000ISOEVA30002026-06-22
00075289522239ISO-MEDISOEVA4000ISOEVA40002026-06-22
00075289522246ISO-MEDISOEVA50ISOEVA502026-06-22
00075289522253ISO-MEDISOEVA500ISOEVA5002026-06-10
00653195276400Safety ZoneBRZ640BRZ6402020-04-16
00075289715532VIRTU-CLEANGL-NCREXSGL-NCREXS2024-11-25
00075289715549VIRTU-CLEANGL-NCRESGL-NCRES2024-11-25
00075289715556VIRTU-CLEANGL-NCREMGL-NCREM2024-11-25
00075289715563VIRTU-CLEANGL-NCRELGL-NCREL2024-11-25
00075289715570VIRTU-CLEANGL-NCREXGL-NCREX2024-11-25
10075289715539VIRTU-CLEANGL-NCREXSGL-NCREXS2024-11-25
10075289715546VIRTU-CLEANGL-NCRESGL-NCRES2024-11-25
10075289715553VIRTU-CLEANGL-NCREMGL-NCREM2024-11-25
70075289715562VIRTU-CLEANGL-NCRELGL-NCREL2024-11-25
10075289715577VIRTU-CLEANGL-NCREXGL-NCREX2024-11-25

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