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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 Sigma Company Limited, manufactured by Dongguan Gusie Intelligent Technology Co Ltd in China. The device registration started on March 25, 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
Class I
Nitrile examination/treatment glove, non-powdered
Australia TGA ARTG Registered Device
Good Name: Sigma Company Limited - Nitrile examination/treatment glove, non-powdered
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Intended Purpose

These are a non-sterile device made of nitrile that are intended to be used as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes and to reduce the risk of cross contamination.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 25, 2021
Effective Date
March 25, 2021
Manufacturer
Country
China
Address
Shijie Town Tangchun Road No 183, Room 804 Dongguan, Guangdong, 523290