510(k) K203775

AIC disposable medical mask by The Aleen International Corporation — Product Code FXX

K203775 is an FDA 510(k) premarket notification submitted by The Aleen International Corporation for the device "AIC disposable medical mask". The FDA issued a decision of Substantially Equivalent on Mar 12, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.