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Hevea-latex examination/treatment glove, powdered - ARTG 460688

Access comprehensive regulatory information for Hevea-latex examination/treatment glove, powdered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 460688 and sponsored by A R Medicom Australia Pty Ltd, manufactured by A R Medicom M Sdn Bhd in Malaysia. The device registration started on August 26, 2024.

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 460688
Class I
Hevea-latex examination/treatment glove, powdered
ARTG ID: 460688
Good Name: A R Medicom Australia Pty Ltd - Hevea-latex examination/treatment glove, powdered
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Intended Purpose

A glove made of Hevea natural rubber latex (NRL) 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 covered with talcum powder to facilitate donning/removal. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
460688
Start Date
August 26, 2024
Effective Date
August 26, 2024
Manufacturer
Country
Malaysia
Address
No 3 Jalan 13/3 3rd Floor Wisma Koon Hoe, Petaling Jaya, Selangor Darul Ehsan, 46200