Surgical Mask-Model Number: Ear Loop, Flat-Pleated

About This 510(k) Submission

K201852 is an FDA 510(k) clearance for the Surgical Mask-Model Number: Ear Loop, Flat-Pleated, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on March 2, 2021, 239 days after receiving the submission on July 6, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.