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Nitrile examination/treatment glove, non-powdered

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 Big Start Pty Ltd, manufactured by Guangdong Kingfa SCI & Tech Co Ltd in China. The device registration started on February 21, 2022.

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
Class I
Nitrile examination/treatment glove, non-powdered
Australia TGA ARTG Registered Device
Good Name: Big Start Pty Ltd - Nitrile examination/treatment glove, non-powdered
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DJ Fang

DJ Fang

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Intended Purpose

The device is a nitrile glove 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 not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 21, 2022
Effective Date
February 21, 2022
Manufacturer
Country
China
Address
No 28 Delong Avenue Shijiao Town Qingcheng District, Qingyuan CIty, Guangdong Province, 511545