510(k) K202316

Medical mask (Model: KKF-1A) by Han Zhaoqing Sporting Goods Company Limited — Product Code FXX

K202316 is an FDA 510(k) premarket notification submitted by Han Zhaoqing Sporting Goods Company Limited for the device "Medical mask (Model: KKF-1A)". The FDA issued a decision of Substantially Equivalent on Mar 3, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Han Zhaoqing Sporting Goods Company Limited has 1 other 510(k) clearance on record.