DID YOU KNOW CDC's recommended KN95 Masks are not legal to purchase by the general public us ( um..like us)?
For the most current CDC recommendations on optimizing respirator use, please visit CDC’s webpage: Strategies for Optimizing the Supply of N95 Respirators. This EUA does not permit use of authorized respirators by the general public. (https://www.fda.gov/media/136664/download)
We still need exceptional filtering protection against COVID 19 better the cloth face covering. Here's how to find right KN95 Mask for the general public use.
Does FDA Clearance matters on Face Mask for General Public Use?
Face masks, face shields, and N95 respirators are devices when they meet the definition of a device set forth in section 201(h) of the FD&C Act. Under section 201(h) of the FD&C Act, these products are devices when they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease.
Other face masks, face shields, and filtering facepiece respirators are marketed to the general public for general, non-medical purposes, such as use in construction and other industrial applications. Because they are not intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, FDA device marketing authorization is not required, and all the other requirements of the FD&C Act do not apply to manufacturers, importers, and distributors of these products.
*Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)
Even though, any KN95 disposable protective mask for general public is not required to authorize by FDA, please make sure the manufacture is registered on FDA. Any manufactures not listed on FDA has a higher chance of producing low-quality of products.
Am I buying the legit KN95 Disposable Protective Mask?
First, check your packaging.
A packaging of legit KN95 Mask discloses its manufacturer information which matches with their Certificate of Compliance.
Second, check their Certificate of compliance.
Many of KN95 suppliers posted fake CE with false information on their website. CEs are always able to verified by the testing lab listed on the original certificate by contact them or on their website.
There’s a few signs you may be able to tell a KN95 mask is counterfeit:
No markings at all on the filtering face piece respirator.
No approval/standard number on the filtering face piece respirator
- Presence of decorative fabric or other decorative add-ons (e.g. sequins, foils etc)
Claims for the approval for children. (NIOSH does not approve any type of respiratory protection for children)
Check out trusted KN95 disposable protective mask, iMato Mask!