April 29, 2020
YOU UNDERSTAND THAT THE CP-95 FACE MASK HAS NOT BEEN CLEARED, APPROVED OR CERTIFIED BY THE FOOD AND DRUG ADMINISTRATION (“FDA”), THE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (“NIOSH”), OR ANY OTHER REGULATORY AGENCY AS A SURGICAL MASK OR RESPIRATOR, AND THEREFORE MAY NOT PROVIDE THE SAME LEVEL OF BARRIER PROTECTION, FLUID RESISTANCE, FILTRATION, AND/OR INFECTION CONTROL AS AN APPROVED RESPIRATORY PROTECTIVE DEVICE. THE CP-95 FACE MASK SHOULD NOT BE CONSIDERED AN ADEQUATE REPLACEMENT FOR A CONVENTIONAL AND APPROVED PERSONAL RESPIRATORY PROTECTIVE DEVICE. YOU FURTHER UNDERSTAND THAT THE CP-95 FACE MASK HAS BEEN AUTHORIZED BY THE FDA UNDER AN EMERGENCY USE AUTHORIZATION ("EUA") FOR USE AS A SOURCE CONTROL BY THE GENERAL PUBLIC AS WELL AS BY HEALTH CARE PERSONNEL IN HEALTH CARE SETTINGS TO HELP PREVENT THE SPREAD OF INFECTION OR ILLNESS DURING THE COVID-19 PANDEMIC. THE CP-95 FACE MASK IS AUTHORIZED ONLY FOR THE DURATION OF THE DECLARATION THAT CIRCUMSTANCES EXIST JUSTIFYING THE AUTHORIZATION OF THE EMERGENCY USE OF MEDICAL DEVICES, INCLUDING ALTERNATIVE PRODUCTS USED AS MEDICAL DEVICES, DURING THE COVID-19 OUTBREAK, UNDER SECTION 564(B)(1) OF THE ACT, 21 U.S.C. § 360BBB-3(B)(1) UNLESS THE AUTHORIZATION IS TERMINATED OR REVOKED SOONER. YOU FULLY ACCEPT THE RISK OF USING A CP-95 FACE MASK AND AGREE TO ASSUME ALL RISK OF PERSONAL INJURY, SICKNESS OR LOSS, BODILY INJURY (INCLUDING DEATH) OCCASIONED TO YOU OR ANY THIRD PARTY, DAMAGE TO OR LOSS OF, OR DESTRUCTION OF ANY PERSONAL PROPERTY RESULTING FROM OR ARISING OUT OF THE USE OF ANY CP-95 FACE MASK, INCLUDING BUT NOT LIMITED TO ANY FAILURE OF THE CP-95 FACE MASK TO PROTECT YOU OR ANY OTHER PERSON FROM THE COVID-19 CORONAVIRUS OR OTHER INFECTIOUS DISEASE.
