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. We have MLH designation under EUA authorization.
Can you customize masks?
Yes! This is a great feature for companies looking for bulk orders. We work directly with our manufacturer. We can engrave your name or logo on the mask and can produce a customized box with FDA-appropriate labeling. There is a minimum order of 600 cartons and a small fee starting at $500.
Do you have kids' masks?
Yes! We currently have in stock a kids surgical mask, which is a high quality, 3-layer mask with great testing scores and is FDA registered.
Do you have KF94 masks?
Yes! We currently have in stock an adult sized KF94 mask, which is a light-weight, high quality 3-layer mask with great testing scores and is FDA registered.
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.