Pure Global

Mask, surgical, single use

Access comprehensive regulatory information for Mask, surgical, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by ProClean (Supplies) Australia, manufactured by Crown Name (WH) United Co Ltd in China. The device registration started on July 20, 2020.

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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Class I
Class I
Mask, surgical, single use
Australia TGA ARTG Registered Device
Good Name: ProClean (Supplies) Australia - Mask, surgical, single use
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Intended Purpose

GMDN 35177. A single-use, disposable face mask with ear loop made from non-woven fabric to be placed over the nose and mouth to act as a protection barrier to minimise contamination and exposure to infectious airborne agents. To be used in Health Care for use in emergency departments, dentistry, changing dressings on small wounds or healing wounds where minimal blood droplet exposure may possibly occur.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 20, 2020
Effective Date
July 20, 2020
Manufacturer
Country
China
Address
Changhang Building RM 1805 No 69 Yanjiang Avenue, Wuhan, Hubei, 430021