Evo9x YW BALLERS Tie Back Double Ply Fabric Face Masks Red Style II- Pack of 10
10 Masks in a pack -Tie Back Fabric Face Masks
- Double ply 100 % polyester knitted fabric
- Open from both ends so you can slide in a filter. Filter not included.
- These masks are made in Edison New Jersey.
- Tie / binding color may vary.
- This Facemask may be used when FDA cleared masks are unavailable;
- We recommend against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected;
- We make no claims of antimicrobial or antiviral protection;
- We make no claims of infection prevention or reduction;
- We make no claims regarding flammability;
- This Facemask is made of 100% polyester;
- This facemask is not a “surgical mask”.
This Facemask is manufactured in accordance with FDA recognition for the urgent need for face masks in the setting of the COVID-19 pandemic due to increased use and shortages in their availability.
The FDA does not object to the marketing and distribution of face masks in the healthcare setting without prior 510(k) clearance if the product is labeled in this manner.
The FDA does not object to marketing of masks that meet the above criteria even if they are manufactured at facilities that do not meet 21 CFR 820.
This information was provided by the Industrial Fabrics Association International from guidance they received from the White House and FDA on March 25th - https://www.ifai.com/2020/03/25/information-on-ppe-product-specifications-for-manufacturing/
Information on PPE Product Specifications for Manufacturing