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 Sleepcraft Distributors Pty Ltd, manufactured by Suzhou Fangtian Industries Co Ltd in China. The device registration started on November 18, 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.
Surgical N95 Particulate Disposable Respirator has been designed specifically for the use in a healthcare setting. While delivering the appropriate amount of filtration efficiency against airborne contaminants, it helps provide a larger breathing chamber with no restriction of downward vision, allowing total facial closure for custom fit on any size face. This respirator may also help reduce breathing in some pathogenic biological airborne particulates, but does not eliminate the risk of infection or disease.

