The products herein are not FDA-approved medical devices:
The information presented herein, including PFFR Shield, Snorkel Mask Shield, and a combination of the two, is intended to assist the general public during the current Global Pandemic related to COVID-19 as well as the resulting shortages of personal protective equipment ("PPE"). These devices are not intended to replace approved and serviceable PPE when it is available. These devices and related information have not been fully tested on humans, peer reviewed, or approved by governmental authorities. Protect-MI.org as well as anyone associated with it, including but not limited to directors, officers, employees, agents, volunteers, and the like, assume no liability and make no express or implied warranties, representations, or guarantees regarding the safety, efficacy, marketability, or appropriate use of these devices. Each user should test each device, including a fit test where applicable, prior to use. Each user accepts all risks related to using or distributing these devices and agrees to indemnify and hold harmless Protect-MI.org as well as anyone associated with it regarding the use thereof.
The following content, including but not limited to project descriptions, preliminary test results, figures/images, and prototypes, published here is meant to maximize potential public benefit during the CoVID-19 crisis (SARS-CoV-2 pandemic), specifically in addressing the urgent need around PPE shortage.
NOTE: Although no determination has been made with respect to this design, the Department of Health and Human Services (DHHS) has declared liability immunity for medical countermeasures against COVID-19. ####