Livocare face mask got FDA 510K cleared in October 2020 and met ASTM F1862/F1862M-17 Level II standards.
510K Number# K201380
iHealth Livocare Face Mask (50 Count), 510K Cleared 3 Ply Disposable Face Mask for Adults Protective Breathable Face Mouth Cover with Nose Clip & Ear Loops, Suitable for Office, School, and Outdoor use.
Disposable face masks are recommended where social distancing measures are difficult to maintain and in areas of significant community-based transmission. These disposable face masks help block exhaled droplets to help prevent the further spread of contagious diseases. These masks are certified under the ASTM F1862/F1862M-17 Level II standard for single-use face masks and meet the requirements outlined in most government directives for wearing face masks in public gatherings.
Comfortable, smooth, and odorless
This mask is made of soft, non-woven fabric that is odorless and soft to the touch to avoid skin irritation. The elastic ear loops are flat and designed to fit the ear without excessive strain.
Meticulous manufacturing process to ensure quality
We searched for only the highest quality manufacturer for these masks. The masks have three precision-folded layers to conform to any face, a bendable nose piece to improve the face mask seal, a lattice hemming-stitched edge to ensure layers stay together, and a solid ear-loop weld so elastics stay attached.
*FDA 510K cleared in October 2020 and the products made before 510K cleared.