510(k) K222426

Perfetta Moderate Medical Face Mask by Phu Bao Group Company Limited — Product Code FXX

K222426 is an FDA 510(k) premarket notification submitted by Phu Bao Group Company Limited for the device "Perfetta Moderate Medical Face Mask". The FDA issued a decision of Substantially Equivalent on Sep 2, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.