Which Mask has been tested for use by Health Care Professionals?
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?
No, our NM-601 (KN95) Face Masks were not part of this FDA action because our masks have been tested and approved under the new requirements of the FDA.
Are your masks NIOSH Approved?
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.
If I purchase some of your N95 Style Face Masks, am I taking supply away from front-line healthcare workers?
Swiftwell masks meet the standards for use by healthcare professionals and they are also acceptable to be used by consumers not involved with healthcare. Front-line COVID-19 workers receive a majority of supplies of personal protection equipment (PPE) from their employer hospitals, clinics and other critical healthcare environment settings from Local authorities, and other organizations such as FEMA, receive mask supplies from other already established supply chains. Swiftwell assists in meeting a need for high quality masks that have passed the stringent filtration tests and can be used for both healthcare professionals and consumers alike, while not interfering with the supply for front-line workers.
What are your Payment Terms?
We require full payment in advance, credit card, PayPal, ACH or wire. With the current world-wide market circumstances due to the SARS-CoV-2 coronavirus pandemic, which include our supplier terms, extraordinary freight and distribution costs for express shipping and fast order processing, our Conditions and Terms of Sale for these products currently require advance pre-payment with each order.
What is the minimum order?
The Minimum order for our Masks is one box of 10 masks.
How soon will my order ship?
General Shipment Time is 3 - 5 days after the receipt of your order. We typically ship via USPS and will provide you a tracking number at the time of shipment.
What is the Shipping Cost?
We ship only to locations within the USA. We offer flat rate shipping of 4.95 per order.
Returns and Refunds?
Because of the personal nature of our products, we must say that all sales are final, so no refunds and no returns will be accepted.
Have a question that wasn’t answered here? Contact us.