510(k) K211165

Medical Face Masks, Model Name:MY020003 by Huizhou Jie Bai Purification Co., Ltd. — Product Code FXX

K211165 is an FDA 510(k) premarket notification submitted by Huizhou Jie Bai Purification Co., Ltd. for the device "Medical Face Masks, Model Name:MY020003". The FDA issued a decision of Substantially Equivalent on Nov 9, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.