What Happened : User
coin163 is selling
Medical Surgical Face Mask Disposable with CE and FDA approved.
Archived. I have send personal messages for ask about the CE and FDA certification, and then he show me from this link.
ArchivedFrom that's link I got many pictures about CE, FDA, and many other packaging from this mask. But I want to show FDA certificate and the packaging only
According to this FDA certificate, the face mask
Product Code: QKR with
Device Class: Not ClassifiedArchivedFrom what I search about the QKR code, it means any face masks with QKR code is Non-Surgical Masks and can't prevent from disease. And only face mask with Product code FXX, MSH, OUK, OXZ with Device class: 2 is recommended and prevent from covid-19 spread
Non-Surgical Masks: Non-surgical face masks not intended for the prevention of disease are NOT regulated by the FDA (FDA Product Code QKR). The FDA has issued guidance that allows enforcement discretion (e.g. not explicitly regulated) for non-surgical face masks intended to be worn by the general public or healthcare personnel. In an ideal world, we would test samples from batches of non-surgical masks – BUT, something is better than nothing and the public/staff can wear homemade non-surgical masks outside of isolation areas if permitted by hospital policy. Click here for pattern recommended by CDC
Honestly I didn't expert about medical things, so I prefer to ask and share your thought about this case. I have contacted coin163 about this and his answer
Hello,
That's FDA certificate I got from Factory.
Thank you for letting me me know about this info.
It's mistaken for surgical mask.
But this kind of masks still better than many unwell know brands from China.
I could connect with new source with surgical mask and FDA Approved if you prefer.
100% made in Vietnam.
Thank you