FDA.reportPublic FDA data

ProWorks

Primary DI
00075289122835
Brand
ProWorks
Company
TRANZONIC COMPANIES, THE
Model
GL-N105FM
Catalog number
GL-N105FM
Device description
ProWorks® GrizzlyNite® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 5 mil, Medium, 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
10075289122832PackageGS110In Commercial Distribution
00075289122835PrimaryGS10
70075289122834Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007528912283210075289122832
00075289122835000752891228350752891228350075289122835
7007528912283470075289122834

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
800-321-9832info@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
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
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
00810145952122NeuleafMedgluv Inc.LZA2026-06-30
00810145952139NeuleafMedgluv Inc.LZA2026-06-30
00810145952146NeuleafMedgluv Inc.LZA2026-06-30
00810145952108NeuleafMedgluv Inc.LZA2026-06-29
00850005229568NeuflexMedgluv Inc.LZA2026-06-29
00850005229575NeuflexMedgluv Inc.LZA2026-06-29
00850005229582NeuflexMedgluv Inc.LZA2026-06-29
00850005229599NeuflexMedgluv Inc.LZA2026-06-29
00850005229605NeuflexMedgluv Inc.LZA2026-06-29
00850005229612NeuflexMedgluv Inc.LZA2026-06-29
00810145951972NeuPro 16Medgluv Inc.LZA2026-06-26
00810145951989NeuPro 16Medgluv Inc.LZA2026-06-26
00810145951996NeuPro 16Medgluv Inc.LZA2026-06-26
00810145952009NeuPro 16Medgluv Inc.LZA2026-06-26
00810145952153NeulynxMedgluv Inc.LZA2026-06-26
10304040194048EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194055EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194062EssentialsHENRY SCHEIN, INC.LZA2026-06-25