In two consecutive documents issued by the Food and Drug Administration (FDA) last week, two brands of disposable masks have been marked as "unnotified medical device product" by the organization.
Both brands—one which appears to be generic and the other under the name AiDeLai—did not go through the evaluation process of the FDA, which means that the quality and safety assurance cannot be vouched for.
The documents are both signed by the agency's director general Rolando Enrique D. Domingo, MD.