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Nitrile examination/treatment glove, non-powdered

Australia TGA ARTG Registered Device · Grace Global Pty Ltd · FIKRISZ (M) SDN BHD · Class I · Started February 10, 2021

Good Name: Grace 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
February 10, 2021
Effective Date
February 10, 2021
Sponsor
Manufacturer
Country
Malaysia
Address
Kompleks Kilang SME Bank No 14, Lorong Saga 1/9 Taman Perusahaan Saga Sungai Petani, Kedah Darul Aman, 08000
Intended purpose

Nitrile examination gloves non-sterile 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 talcum powder. This is a single-use device.

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 Grace Global Pty Ltd, manufactured by FIKRISZ (M) SDN BHD in Malaysia. The device registration started on February 10, 2021.

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.

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