510(k) K202137

Disposable medical mask by U-Play Products Corporation — Product Code FXX

K202137 is an FDA 510(k) premarket notification submitted by U-Play Products Corporation for the device "Disposable medical mask". The FDA issued a decision of Substantially Equivalent on Mar 4, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.