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Nitrile examination/treatment glove, non-powdered - ARTG 372554

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 372554 and 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.

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TGA ARTG Official Data
Class I
ARTG 372554
Class I
Nitrile examination/treatment glove, non-powdered
ARTG ID: 372554
Good Name: PR Biz Assist Pty Ltd - Nitrile examination/treatment glove, non-powdered
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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.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
372554
Start Date
August 10, 2021
Effective Date
August 10, 2021
Manufacturer
Country
Malaysia
Address
Lot 1422-1424 Batu 10 Lekir, 32020 Sitiawan, PERAK DARUL , Ridzuan, 0