Australia TGA ARTG record

Polychloroprene examination/treatment glove, non-powdered

Australia TGA ARTG Registered Device · PR Biz Assist Pty Ltd · PT Medisafe Technologies · Class I · Started July 01, 2020

Good Name: PR Biz Assist Pty Ltd - Polychloroprene examination/treatment glove, non-powdered

Device classification

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

Registration information

Start Date: July 01, 2020
Effective Date: July 01, 2020

Sponsor

Name: PR Biz Assist Pty Ltd

Manufacturer

Name: PT Medisafe Technologies
Country: Indonesia
Address: Jl Batang Kuis gg Tambak Rejo/Pasar IX Desa Buntu Bedimbar Tanjung Morawa, Medan, Sumatera Utara, 20362

Intended purpose

This medical device is a single-use, non-sterile, non-latex, polychloroprene disposable gloves. It is intended to be used as a protective barrier for hands by doctors, dentists and other medical practitioners used during patient examination. Its primary purpose is to protect both the medical staff and patients from contamination from each other and latex allergy. This is a non-powdered glove. It is also intended to be used in the food handling process and for household hand protection/sanitary.

About this record

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 PR Biz Assist Pty Ltd, manufactured by PT Medisafe Technologies in Indonesia. The device registration started on July 01, 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.