FDA.reportPublic FDA data

Tronex International, Inc.

Primary DI
10097604870006
Brand
Tronex International, Inc.
Company
TRONEX INTERNATIONAL, INC.
Model
8700-05
Device description
Glove, Exam, Synthetic Vinyl, SynTech, Powder-Free, Latex-Free, Natural, Extra-Small
Published
2024-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Contact Domains#

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
10097604870006PrimaryGS10
00097604870009Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1009760487000610097604870006
00097604870009000976048700090976048700090097604870009

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.

Contacts#

Phone, Email table
PhoneEmail
973-335-2888tronexproductmanagement@tronexcompany.com

Regulatory Flags#

DUNS number
615425519
Device count
1000

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10097604912805Tronex International, Inc.9128-052022-10-28
10097604912812Tronex International, Inc.9128-102022-10-28
10097604912829Tronex International, Inc.9128-202022-10-28
10097604912836Tronex International, Inc.9128-302022-10-28
10097604912843Tronex International, Inc.9128-352022-10-28
10097604912850Tronex International, Inc.9128-402022-10-28
10097604599921Tronex International, Inc.5999C2025-09-10
10097604451250Tronex International, Inc.SMS45125Y2022-10-28
10097604453353Tronex International, Inc.SMS45335Y2022-10-28
10097604555514Tronex International, Inc.5555W2025-07-28
00097604555517Tronex International, Inc.5555W2025-07-28
10097604577028Tronex International, Inc.577025W2025-07-24
10097604577042Tronex International, Inc.577035W2025-07-24
00097604577021Tronex International, Inc.577025W2025-07-24
00097604577045Tronex International, Inc.577035W2025-07-24
10097604110577Tronex International, Inc.TLB1105L2025-05-05
10097604130582Tronex International, Inc.TCB0305C2025-05-01
10097604140581Tronex International, Inc.TCB0405C2025-05-01
10097604160589Tronex International, Inc.TCB0605C2025-05-01
10097604220580Tronex International, Inc.TLB2205L2025-05-01

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
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
10813172024593DermAssist®INNOVATIVE HEALTHCARE CORPORATIONLYZ2023-08-28