Home GUDID 00097604904711 Tronex International, Inc.
Primary DI 00097604904711
Brand Tronex International, Inc.
Company TRONEX INTERNATIONAL, INC.
Model 9047-10
Device description Glove, Exam, Nitrile, Fingertip-Textured, Powder-Free, Latex-Free, Black
Published 2022-10-28
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name LZA Polymer Patient Examination Glove
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LZA Polymer Patient Examination Glove General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10097604904718 Primary GS1 0 00097604904711 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10097604904718 10097604904718 00097604904711 00097604904711 097604904711 0097604904711
GMDN Terms# Term, Definition table Term Definition Nitrile examination/treatment glove, non-powdered, non-antimicrobial A 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.
Regulatory Flags# DUNS number 615425519 Device count 1000 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false 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 DI Brand Model Catalog Published 10097604912805 Tronex International, Inc. 9128-05 2022-10-28 10097604912812 Tronex International, Inc. 9128-10 2022-10-28 10097604912829 Tronex International, Inc. 9128-20 2022-10-28 10097604912836 Tronex International, Inc. 9128-30 2022-10-28 10097604912843 Tronex International, Inc. 9128-35 2022-10-28 10097604912850 Tronex International, Inc. 9128-40 2022-10-28 10097604599921 Tronex International, Inc. 5999C 2025-09-10 10097604451250 Tronex International, Inc. SMS45125Y 2022-10-28 10097604453353 Tronex International, Inc. SMS45335Y 2022-10-28 10097604555514 Tronex International, Inc. 5555W 2025-07-28 00097604555517 Tronex International, Inc. 5555W 2025-07-28 10097604577028 Tronex International, Inc. 577025W 2025-07-24 10097604577042 Tronex International, Inc. 577035W 2025-07-24 00097604577021 Tronex International, Inc. 577025W 2025-07-24 00097604577045 Tronex International, Inc. 577035W 2025-07-24 10097604110577 Tronex International, Inc. TLB1105L 2025-05-05 10097604130582 Tronex International, Inc. TCB0305C 2025-05-01 10097604140581 Tronex International, Inc. TCB0405C 2025-05-01 10097604160589 Tronex International, Inc. TCB0605C 2025-05-01 10097604220580 Tronex International, Inc. TLB2205L 2025-05-01
Other Devices Sharing Product Codes#