Required publication by the U.S. Food & Drug Administration (FDA) regarding intended use and other information:This product meets the performance standard for GB 2626-2019. It has been tested and approved by the Chinese National Medical Products Administration (NMPA). Per the US. Food and Drug Administration, this product is imported as a KN-95 mask as a “compassionate use/emergency device”. Per the U.S. Center for Disease Control (CDC) “non-NIOSH-approved products developed by manufacturers who are not NIOSH approval holders should only be used in crisis situations when no other NIOSH-approved N95 respirator is available. They should not be used during aerosol generating medical procedures unless the alternative is a loose-fitting surgical mask or improvised device.” Furthermore, Non-NIOSH approved products developed by manufacturers who are not NIOSH approval holders are expected to meet the performance requirements if they have been issued a certificate of approval by an authorized test laboratory indicating they conform to certain standards. This product meets those standards. Please visit:https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html#crisis
Methodology: Thirty respirators were submitted for evaluation and tested using a modified version of NIOSH Standard Test Procedure (STP) TEB-APR-STP-0059. Only particulate filter efficiency was assessed. The results of a filter penetration test can only be used to provide a check of the product’s filter efficiency. No conclusions can be made regarding equivalency to N95 products that are NIOSH approved. These assessments were developed as an assessment of the filter efficiency represented as certified by an international certification authority, other than NIOSH, to support the availability of respiratory protection to US healthcare workers and other workers due to the respirator shortage associated with COVID-19.