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To export masks to the USA you first need to identify your product code This is the determining factor for whether you need FDA clearance or NIOSH-Approval COVID-19 has made its way to the United States and has led to a nationwide shortage of face masks

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2020/3/27On March 25 2020 the Food and Drug Administration (FDA) issued a temporary policy relating to enforcement of regulatory requirements for face masks and respirators during the COVID-19 crisis Since the public health emergency began the United States has experienced a shortage of masks respirators and other personal protective equipment (PPE) which are critically needed for

We have also found some that are downright misleading like claiming FDA/CDC approval without being on the approved list or FDA database as class 2 medical devices with verified 510k reviews We would also see test reports that show the mask having a BFE of over 98% but their PFE is less than 90%

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2020/3/27On March 25 2020 the Food and Drug Administration (FDA) issued a temporary policy relating to enforcement of regulatory requirements for face masks and respirators during the COVID-19 crisis Since the public health emergency began the United States has experienced a shortage of masks respirators and other personal protective equipment (PPE) which are critically needed for

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Masks are FDA cleared Respirators Respirators meet the CDC Guidelines for Mycobacterium tuberculosis exposure control They are certified by NIOSH as N95's and designed to provide a secure face-to-respirator seal This seal helps reduce the wearer's

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