510(k) K220824

Medical Surgical Mask (Planar type) by Hunan Chopard Medical Devices Co., Ltd. — Product Code FXX

K220824 is an FDA 510(k) premarket notification submitted by Hunan Chopard Medical Devices Co., Ltd. for the device "Medical Surgical Mask (Planar type)". The FDA issued a decision of Substantially Equivalent on May 19, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.