The Food and Drug Administration (FDA) has warned the public and hospitals in general against buying two face mask brands: “AINBE” and “Day Maker.”
FDA chief Eric Domingo said that face masks bearing the “Day Maker Disposable Face Mask” and “AINBEI Disposable Protective Masks” labels could prove to be unreliable since these had not yet received the official seal of approval from authorities.
“Since these medical device products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety,” an advisory dated Nov. 6, 2020 said.
Domingo said such face masks must be registered with the FDA and issued product notification certificates before being sold on the open market.
Otherwise, they cannot be advertised as “medical grade” or for use in hospital settings.