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Vinyl examination/treatment glove, powdered - ARTG 353313

Access comprehensive regulatory information for Vinyl examination/treatment glove, powdered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 353313 and sponsored by Sigma Company Limited, manufactured by Guangdong Guyun Medical Technology Co Ltd in China. The device registration started on January 19, 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 353313
Class I
Vinyl examination/treatment glove, powdered
ARTG ID: 353313
Good Name: Sigma Company Limited - Vinyl examination/treatment glove, powdered
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Intended Purpose

This is a non-sterile device made of vinyl that is intended to be used as a protective barrier when worn on the hands of healthcare providers both medical and dental during patient examination/treatment that has an inner surface covered with talcum powder to facilitate donning/removal.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
353313
Start Date
January 19, 2021
Effective Date
January 19, 2021
Manufacturer
Country
China
Address
Three Gorges Resettlement Group Jigongkeng Village Futian Town Boluo County, Huizhou City, Guangdong Province