510(k) K202899

Procedure Mask, Surgical Mask by Kenpax International Limited — Product Code FXX

K202899 is an FDA 510(k) premarket notification submitted by Kenpax International Limited for the device "Procedure Mask, Surgical Mask". The FDA issued a decision of Substantially Equivalent on May 20, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Kenpax International Limited has at least 3 other 510(k) clearances on record.