Frequently Asked Questions
Which Mask has been tested for use by Health Care Professionals?
Yes, our Swiftwell KN95 Face Mask (NM-10) conforms with standards set by the FDA to be an authorized substitute for the NIOSH approved N95 Respirator and thus may be used by Health Care Professionals in healthcare settings.
Because of the shortages of NIOSH approved N95 face masks resulting from the COVID-19 outbreak, the FDA issued an Emergency Use Authorization (EUA) on March 2, 2020 to authorize and allow certain N95 masks that are certified in other countries, such as Australia and Canada, to be imported and used in healthcare settings on a temporary basis. On March 28th, the FDA expanded this to include KN95 face masks made in China.
The most recent update to this EUA dated May 8th 2020, reversed the KN95 authorization and now only authorizes imported masks manufactured in China as a KN95 masks to be allowed under this EUA only when these masks are independently certified under US Standards.
Stringent procedures to import FDA – EUA N95 NIOSH types of facial mask respirators to be imported into the USA from China. Under the new requirements for EUA Covid-19 exception by FDA (and therefore allowed for use by U.S. healthcare personnel in a healthcare setting), the face masks must meet standards set both in China and the United States:
First, approval to export the masks from China must be completed by the China government. This mask type must be tested in China for the KN95 Specification / Executive Standard: GB 2626-2006. The ZK Model 601 (KN95) mask was tested by a certified and approved by an independent China laboratory and passed the test standard requirements allowing the Model 601 (KN95) mask to be officially approved with the China National government and the Guangdong China Provincial local government (FDA) equivalent in China approval.
Secondly, for export to the USA, the FDA conditions for approval of the masks under EUA approval, the China manufacturing facility is required to demonstrate a second Country accredited laboratory test. Swiftwell Model NM-601 has been tested under these test standards requirements and have passed the CE (European) test as well.
The FDA has concluded and approved our Model Number: NM-10 (KN95) mask and it has been added to Appendix A of the EUA eligibility criteria in the June 06, 2020 EUA list for non-NIOSH respirators made in China. As such, these respirator models are authorized for use by healthcare personnel in healthcare settings in accordance with CDC recommendations and subject to the Conditions of Authorization.
I’ve read the FDA has removed the authorization for over 75% of the imported N95 Style masks because they are defective. Were your masks part of this purge?
Are your masks NIOSH Approved?
The short answer is no. The Swiftwell Model NM-10 face mask respirator has not been completely tested for all aspects of the NPPTL (NIOSH) N95 mask test. However, the FDA has issued an Emergency Use Authorization (EUA) to allow certain imported N95 style masks that have been certified in other countries to be authorized for use in healthcare settings (see above), with the primary test being the Bacterial Filtration Efficiency (BFE) test.
Swiftwell Model NM-10 mask passed the N95-BFE test as performed by the NPPTL, the independent testing facility established by Congress under the Center for Disease Control for testing for NIOSH approval. This specific BFE test is performed on special NIOSH laboratory equipment for the testing of filtration materials and devices that are designed to provide protection against biological aerosols, such as face masks, surgical gowns, caps, and air filters. This is the most critical test aspect for proving a mask test specimen meets consistently correct maximum and minimum performance range for a N95 style NIOSH safety approval.