Australia TGA ARTG record

Nitrile examination/treatment glove, non-powdered

Australia TGA ARTG Registered Device · Amadex Global Pty Ltd · MEGINE INDUSTRIES SDN BHD · Class I · Started June 11, 2020

Good Name: Amadex Global Pty Ltd - Nitrile examination/treatment glove, non-powdered

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: June 11, 2020
Effective Date: June 11, 2020

Sponsor

Name: Amadex Global Pty Ltd

Manufacturer

Name: MEGINE INDUSTRIES SDN BHD
Country: Malaysia
Address: B-05-02 The Vertical Business Suites No 8 Jalan Kerinhi, Bangsar South, Kuala Lumpar, 59200

Intended purpose

A non-sterile nitrile glove intended as a protective barrier when worn on the hands of health care providers during patient examination/ treatment or for other sanitary purposes.

About this record

Access comprehensive regulatory information for Nitrile examination/treatment glove, non-powdered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Amadex Global Pty Ltd, manufactured by MEGINE INDUSTRIES SDN BHD in Malaysia. The device registration started on June 11, 2020.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.