FAQs

What is ASTM?

ASTM International sets the preferred international standard in healthcare for best practices inclusive of testing and requirements for performance of materials.  Our masks are tested to be ASTM2, considered a “procedure” mask, and ASTM3, considered a “surgical” mask. 

 

What does FDA approval mean?

The FDA, who oversees the sale and marketing of all surgical masks in the U.S., recommends that manufacturer demonstrate mask performance in 4 areas: 1) Fluid Resistance, 2) Differential Pressure, 3) Filter Efficiency, and 4) Flammability.

Perfetta masks have gone through the scrutiny of these evaluations to show its performance.  We are pending the final stage of 510K clearance which will allow us to distribute to hospitals.

 

What certifications do we have?

Our manufacturer is ISO 9001:2015 designated and FDA approved.  Our masks are CE marked (UK equivalent to FDA).  Our masks are Nelson-rated with ASTM F2100-11 and ISO 13485:2016 for medical devices. 

 

Do you have kids' masks?

Perfetta has a children's mask in production that is successfuly sold overseas.  We are working on getting FDA approval before offering for sale. 

 

How do I properly dispose of my mask?

PPE waste can be a health hazard to other humans as well as wildlife and natural ecosystems.  Place your used mask into a plastic bag and then throw it away into a bin with a closed lid.  Masks cannot be buried in the ground or recycled easily.  Do not place in a blue recycling bin.  It can get recycling staff sick and can also clog up the machines.  Look into zero-waste recycling companies.