The KN95 Respirator is a single-use respirator mask for use in protection for mechanically generated dust, mists, fumes, and particles. Certified to meet Chinese Standard GB2626-2019. Featuring multiple layers of lightweight material, the mask provides comfort and breathability with two ear loops or horizontal ties to hold the mask in place.
- Certified to meet GB2626-2019 Respirator standard
- Particulate Filtration Efficiency (PFE) 95%
- Included on the TGA Australian Register of Therapeutic Goods (ARTG) from June 2020
- FDA certification
- Flat fold particulate respirator without exhalation valve
|Characteristics||Testing Criteria||Testing Method||Test Facility|
|Bacterial Filtration Efficiency % (BFE)||95%||GB2626-2019||GQT1951 LAB (CNAS)|
|Inhalation resistance||≤210||GB2626-2019||GQT1951 LAB (CNAS)|
|Exhalation resistance||≤210||GB2626-2019||GQT1951 LAB (CNAS)|
|Flammability||No more than 5
|GB2626-2019||GQT1951 LAB (CNAS)|
Nallawilli Protect Masks – Additional Information
|A D D I T I O N A L I N F O R M A T I O N|
|Nallawilli Protect KN95 Respirator||Click Here|
|Nallawilli TGA Certificate||Click Here|
|Certificate and Schedule||Click Here|
Inclusion on the TGA Australian Register of Therapeutic Goods (ARTG) – from September 2020
TCG single-use PPE masks have been designed for therapeutic use, as they are intended to reduce or prevent the transmission of disease or micro-organisms which meet the definition of a medical device. Medical device products are regulated by the TGA under the Therapeutic Goods Act 1989. Before supply in Australia, these goods need to be included on the ARTG.
To meet the requirements for inclusion on the Register, TCG must meet requirements for product quality, safety and performance in accordance with Australian or international standard requirements. This pre-market data is provided for assessment, and market authorisation is then granted to allow entry of the therapeutic goods to the ARTG.