FDA.reportPublic FDA data

GenMed

Primary DI
00850046948053
Brand
GenMed
Company
Gen-Med LLC
Model
GMVFE402
Device description
Vinyl Glove Exam Medium
Published
2023-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850046948050PackageGS110In Commercial Distribution
00850046948053PrimaryGS10
85004694805300Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004694805010850046948050
00850046948053008500469480538500469480530850046948053
8500469480530085004694805300

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
103053061
Device count
100

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850046948046GenMedGMVFE4012023-03-01
00850046948060GenMedGMVFE4032023-03-01
10850046948043GenMedGMVFE4012023-03-01
10850046948050GenMedGMVFE4022023-03-01
10850046948067GenMedGMVFE4032023-03-01
00850046948077GenMedGMVFE4042023-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20193489081562MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081586MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081593MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
10889483584446AirLife™AIRLIFELYZ2025-02-14
20197344098184SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-27
20197344098160SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098177SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098191SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
10860011916618Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916625Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916632Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916649Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916656Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10810141931265VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931272VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931289VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931296VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931302VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10097604870006Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870013Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870020Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870037Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870044Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10755676000843ADI MedicalADI MedicalLYZ2023-11-27
10755676000850ADI MedicalADI MedicalLYZ2023-11-27
10755676000867ADI MedicalADI MedicalLYZ2023-11-27
10755676001482ADI MedicalADI MedicalLYZ2023-11-27
10755676001499ADI MedicalADI MedicalLYZ2023-11-27
10755676001512ADI MedicalADI MedicalLYZ2023-11-27
10813172024609DermAssist®INNOVATIVE HEALTHCARE CORPORATIONLYZ2023-09-01