Australia TGA ARTG record

Nitrile examination/treatment glove, non-powdered

Australia TGA ARTG Registered Device · PR Biz Assist Pty Ltd · Yty Industry Sdn Bhd · Class I · Started August 10, 2021

Good Name: PR Biz Assist 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: August 10, 2021
Effective Date: August 10, 2021

Sponsor

Name: PR Biz Assist Pty Ltd

Manufacturer

Name: Yty Industry Sdn Bhd
Country: Malaysia
Address: Lot 1422-1424 Batu 10 Lekir, 32020 Sitiawan, PERAK DARUL , Ridzuan, 0

Intended purpose

This medical device is a single-use, non-sterile, non-latex, nitrile 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 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 PR Biz Assist Pty Ltd, manufactured by Yty Industry Sdn Bhd in Malaysia. The device registration started on August 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.