ISO 13485, For Medical Devices

Lutema masks and respirators are manufactured in the USA from nationally and globally sourced, premium quality materials. Materials are tested periodically per ISO 13485 organizational standards; further, we require vendors to continually test materials for particle filtration and bacterial filtration efficacy before we receive it ensuring the highest quality product possible.

American Medical Manufactures Association

AMMA American Medical Manufactures Association

In addition to our commitment to bringing PPE manufacturing back to the US, we are founding members of AMMA, the American Medical Manufacturers Association.