Pure Global

Polychloroprene examination/treatment glove, non-powdered

Access comprehensive regulatory information for Polychloroprene 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 Thermo Fisher Scientific Australia Pty Ltd, manufactured by PT Medisafe Technologies in Indonesia. The device registration started on October 08, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
Polychloroprene examination/treatment glove, non-powdered
Australia TGA ARTG Registered Device
Good Name: Thermo Fisher Scientific Australia Pty Ltd - Polychloroprene examination/treatment glove, non-powdered
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

A non-sterile single-use device made of polychloroprene (neoprene) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 08, 2021
Effective Date
October 08, 2021
Manufacturer
Country
Indonesia
Address
Jl Batang Kuis gg Tambak Rejo/Pasar IX Desa Buntu Bedimbar Tanjung Morawa, Medan, Sumatera Utara, 20362