Surgical/medical respirator, single-use
Access comprehensive regulatory information for Surgical/medical respirator, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by PRIVATE BRANDS PTY LTD, manufactured by Shanghai Dasheng Health Products Manufacturer Co Ltd in China. The device registration started on August 15, 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.
A filtering AS/NZS 1716:2012 P2 and AS 4381:2015 Level 3, Single-use Non-Sterile face mask for use in Surgical and Health Care with filter efficiency greater than 94%, designed to be placed over the nose and mouth of a member of the Hospital, Health care staff and general public to protect the wearer from large and small particles when considered necessary (e.g., viral epidemic, fluid resistance). It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create a seal against the user's face and typically secured using elastic head loops or ties; it may incorporate a forming nose piece (metal wire) and/or an exhalation valve. This is a single-use device.