FDA.reportPublic FDA data

ProWorks

Primary DI
00075289122866
Brand
ProWorks
Company
TRANZONIC COMPANIES, THE
Model
GL-N105FXXL
Catalog number
GL-N105FXXL
Device description
ProWorks® GrizzlyNite® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 5 mil, XX-Large, 100/bx, 10 bxs/cs
Published
2020-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10075289122863PackageGS110In Commercial Distribution
00075289122866PrimaryGS10
70075289122865Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007528912286310075289122863
00075289122866000752891228660752891228660075289122866
7007528912286570075289122865

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.

Contacts#

Phone, Email table
PhoneEmail
8003219832info@hospeco.com

Regulatory Flags#

DUNS number
007900020
Device count
100

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
00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22
00850084857362MedClickMedClick LLCLZA2026-07-22
00850084857379MedClickMedClick LLCLZA2026-07-22
00850084857386MedClickMedClick LLCLZA2026-07-22
00850084857393MedClickMedClick LLCLZA2026-07-22
00850084857409MedClickMedClick LLCLZA2026-07-22
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06