MIT testing revealed that some masks distributed by the state were filtering less than 30%. The Chinese government said it's now cracking down and seizing 89 million shoddy masks. But it's unclear how many of them have already made their way to the US. We have found that over 90% of the KN95 respirators were unacceptable because they were either counterfeit or labeled incorrectly. Since many of you do not know about the FDA regulations and why medical providers need high-quality N95 respirators, please let us guide you.
iMato Disposable Protective Mask Vs. Other KN95 Mask
FDA logo on the box
FDA does NOT allow a vendor to put the FDA logo on the box of a respirator. So, if your Chinese KN95 respirator has an FDA logo on the box, then you are probably importing a non-authorized KN95 respirator. This is the easiest way to help spot a KN95 that is NOT FDA approved. Let me say this again: If the box or the label says FDA, then it is DEFINITELY NOT FDA APPROVED. Thankfully, the Ministry of Commerce in China has recently started to crack down on its own export along with the FDA guidelines.
iMato Disposable Protective Mask well complies FDA guideline and all of iMato Disposable Protective Mask meet the regulatory requirements of both the U.S. Bureau of Customs and Border Protection (CBP) and FDA.
CE Certificate of Compliance
( above image: iMato Certificate of Compliance No. 5C200404E.SIT00088)
( above image: unverified certificates )
Unfortunately, we (the European Safety Federation = trade association of suppliers of PPE) are informed by different sources about ‘certificates’ or other documents used as basis for CE marking of PPE (including FFP2/FFP3 masks and eye protection), while these ‘certificates’ have no legal value and can not be used as conclusion of conformity assessment. It is not clear if these documents have actually been issued by the organizations mentioned themselves or if they are fake. Most of testing lab have a feature on their website to verify the certificate. You can easily find their website address mention on CE, need to verify. to verify the Certificate of Compliance of iMato Disposable Protective mask, please visit Ente Certificazione Macchine Srl at http://entecerma.it and go to 'Certificate Verification' CE No. 5C200404E.SIT00088. Anyone can simply create their account and able to search the certificate.
Many of KN95 suppliers post the FDA certificate on their website/online store which cannot be found on FDA official website. Any international establishments who manufactures and export their mask to U.S must registered and complies FDA regulation. Please visit the FDA website for more information, click here.
Most of KN95 comes in clear packaging without manufacturer information nor distributors information.
According to Newsweek.com on 4/27/20, the Chinese government has reportedly taken control of medical mask production as demand for supplies soars worldwide amid the coronavirus pandemic.
Faulty goods are at least one of the reasons China has taken more control of mask production and export. As Beijing pivoted to assisting other nations with the pandemic, some European nations complained that equipment received was inadequate. Beijing subsequently introduced quality control measures on exports to avoid such embarrassing incidents.
On Saturday authorities introduced new measures for medical products, declaring that all exports had to meet Chinese and international regulatory standards. All exporters must now file a written declaration confirming that their products meet the safety requirements of the destination country, the ministry of commerce said, according to AFP.
Official U.S. Distributor of iMato product, 5Pointz Clothing,Inc. confirmed that iMato Disposable Protective Masks currently in-stock at Kutnhaus.com manufactured on May 7th,2020, exported from China ( of course, meeting Chinese and internationla regulatory standards) and arrived on May 13th, 2020 at U.S Custom border by submitting the required entry information.
So that means, iMato Disposable Protective Mask is the most reliable KN95/FFP2 mask for the general public use!
* For healthcare personnel, please find the non-NIOSH-Approved Imported respirators authorized under EUA by visiting CDC's Website. This EUA does not permit use of authorized respirators by the general public.