510(k) K201852

Surgical Mask-Model Number: Ear Loop, Flat-Pleated by Huizhou Foryou Medical Devices Co., Ltd. — Product Code FXX

K201852 is an FDA 510(k) premarket notification submitted by Huizhou Foryou Medical Devices Co., Ltd. for the device "Surgical Mask-Model Number: Ear Loop, Flat-Pleated". The FDA issued a decision of Substantially Equivalent on March 2, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Huizhou Foryou Medical Devices Co., Ltd. has at least 10 other 510(k) clearances on record.