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Nitrile examination/treatment glove, non-powdered - ARTG 388234

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 registered under ARTG number 388234 and sponsored by Grace Global Pty Ltd, manufactured by Hong Seng Gloves Sdn Bhd in Malaysia. The device registration started on May 10, 2022.

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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TGA ARTG Official Data
Class I
ARTG 388234
Class I
Nitrile examination/treatment glove, non-powdered
ARTG ID: 388234
Good Name: Grace Global Pty Ltd - Nitrile examination/treatment glove, non-powdered
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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

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
388234
Start Date
May 10, 2022
Effective Date
May 10, 2022
Manufacturer
Country
Malaysia
Address
Lot 97 Jalan 10 Kawasan Perusahaan Bakar Arang, Sungai Petani, Kedah Darul Aman, 08000