Australia TGA ARTG recordPublic face mask, single-use
Australia TGA ARTG Registered Device · Big Start Pty Ltd · Taizhou Donghaixiang Protective Equipment Co Ltd · Class I · Started September 06, 2022
Good Name: Big Start Pty Ltd - Public face mask, single-use
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- September 06, 2022
- Effective Date
- September 06, 2022
- Country
- China
- Address
- No 3091 Dunan Road Duqiao Town, Linhai City, Zhejiang, 317016
AS4381:2015 Level 3 (EN14683:2019) surgical style mask that is intended to be flexible and loose-fitting that has been designed to be placed over the mouth and nose of clinicians and/or members of the general public. The medical device has been designed to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). The surgical style is made of a flexible, porous fabric that is secured to the wearer of the mask with with ear loops. The mask incorporates a forming nosepiece (metal wire). This is a single-use device.
Access comprehensive regulatory information for Public face mask, single-use 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 Taizhou Donghaixiang Protective Equipment Co Ltd in China. The device registration started on September 06, 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.