HomeProductsPre-order

CP-95 Declaration of Use and Disclaimer

April 29, 2020

Declaration of Personal Use for Source Control:

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.

  • Change the filter frequently – dispose of used material and replace only with appropriate filter material.
  • We will continue to update our CP-95 Face Mask website with appropriate filter material, supply chain announcements and suggestions.
  • The CP-95 Face Mask is approved only for source control and not as a respiratory protective device and should only be used in settings without concern for verbal communication because face mask muffles sound.
  • Efficiency of filter is dependent on the filter material used. Individual user needs to consult the filter manufacturer specifically for use suggestions.
  • Filter currently provided with the CP-95 Face Mask is obtained from Technostat® 70 double laminated scrim cut to fit the CP-95 filterstem.  Technostat® 70 double laminated scrim filters have NOT been evaluated for this use or application and are NOT deemed to meet NIOSH or FDA respirator regulations.
  • It is important to have a tight, comfortable fit for any respirator style mask like the CP-95. For best fit guidance, please visit  https://www.cdc.gov/niosh/npptl/hospresptoolkit/fittesting.html

Continuing to use this site you agree to our Cookie Policy.
Got it.

This browser is not currently supported. Please try using a different browser.