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Certifications

Our Mask Certifications

Face Mask certifications from accredited and certified independent US testing labs are an absolutely essential requirement when purchasing an effective facial mask for healthcare and clinical settings.  Otherwise, there is a risk for the wearer’s own health and persons within the mask wearers immediate environment.
 
Swiftwell invests the necessary time and resources to obtain and assure the proper US approvals for our face masks. All mask models offered by Swiftwell have achieved test certification for filtration efficiency scores of >99.5%.

USA Testing Lab Results

Swiftwell Protective Face Mask Model NM-10 is a N95 style face mask that qualifies as an FDA-EUA approved respirator. This means it can be used by healthcare professionals in healthcare settings.  As such, it can be named a non-NIOSH approved N95 face mask as authorized by the FDA.

Multiple tests for the Swiftwell mask Model NM-10 have been performed by accredited and certified independent testing facilities. The Bacterial Filtration Efficiency (BFE) test is performed on filtration materials and devices that are designed to provide protection against biological aerosols, such as face masks, surgical gowns, caps, and air filters. The Swiftwell Model NM-10 face mask has passed the N95-BFE test procedures achieving a rating for Bacterial Filtering Efficiency for a mean particle size (MPS) of 3.0 ± 0.3 μm   > 99.7% for filtering efficiency.  Click here to read the NPPTL report.

Temporary FDA Authorization

The Swiftwell KN95 Face Mask (NM-10) conforms and meets 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 type 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 the FDA EUA only when these masks models are independently certified under US Standards.

In order to for the Swiftwell Model NM-10 masks to be imported into the USA from China manufacturing facilities, the mask model must meet the FDA’s revised new requirements for EUA Covid-19 exception by FDA. Therefore, the face masks must meet standards set both in China under specification (KN95 GB2626-2006) and the United States FDA EUA Test Guidelines:
 
First, approval to export the masks from China must be completed with the China government Health and Standards agencies. The mask model must be tested in China by a government approved, licensed and certified independent laboratory specifically licensed for the testing of the KN95 Specification / Executive Standard: GB 2626-2006. The Swiftwell NM Model 601 (KN95) mask was tested by a certified and approved independent China laboratory and passed the test standard requirements allowing our Model NM-10 mask to be officially approved with the China National government and the Guangdong China Provincial local government (FDA) equivalent in China for approval to export under this specification.

Secondly, for N95 type masks approved for used by healthcare personnel in healthcare settings to be imported into the USA, the FDA conditions for approval of the masks under the current FDA EUA requirements and approval of the China manufactured mask is required to demonstrate a second Country accredited laboratory test result. The Swiftwell Model NM-10 has demonstrated this model has 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 FDA EUA list and CDC NIOSH NPPTL standards 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.