BEWARE: FDA warns public of these face masks, lifts hold on one local brand

Published March 5, 2021, 2:01 PM

by Jane Kingsu-Cheng

These disposable masks are not going anywhere any time soon. It will be part of our lives for the time being, so we better make sure that we purchase brands that have been approved by the Food and Drug Administration (FDA).

Recently, FDA has announced in their advisory number 2021-0236 that these two masks have not been approved: Cigilena KN95 folded protective mask and Wistech UV mask surgical face mask.

Another memo was released under the number 2021-0106, listing three more face masks that are not accredited: KF94 face mask, Mediplus disposable face mask, and Mccons KN95 mask.

All of these did not pass the requirements or did not even submit requirements to FDA. There is no corresponding Product Notification Certificate that has been issued. Thus, they did not pass quality and safety requirements. The Bureau of Customs is also reminded not to accept entry of these unnoticed products.

At the same time, advisory number 2020-2185 has been lifted. FDA has also cleared Mega Soft Hygienic Products, Inc from distributing Cherub Daily Protective Mask. The company was able to meet the requirements of the FDA, including the removal of misleading claim of “three-layered bacteria filtered face mask for maximum protection and comfort.” They also added the non-medical use on the packaging.