Pro Facemask Level 3 Surgical masks are classified as a Class I (non-sterile) medical device. Our masks have been reviewed and approved by TGA to be included in Australian Register of Therapeutic Goods. Meets AS4381:2015 ASTM F2100 (Level 3) , EN14683 Type IIR standards.
The TGA (Therapeutics Goods Administration) review ensures masks are manufactured to ensure the highest Medical Device standards, procedures and compliance in accordance with TGA’s Essential Principles.
2yrs too late sunshine for the price gouging.
How do we find it on the TGA site?
https://www.tga.gov.au/testing-face-masks-and-respirators