510(k) K202491

Disposable Surgical Face Mask by Jiangsu Newvalue Medical Products Co., Ltd. — Product Code FXX

K202491 is an FDA 510(k) premarket notification submitted by Jiangsu Newvalue Medical Products Co., Ltd. for the device "Disposable Surgical Face Mask". The FDA issued a decision of Substantially Equivalent on January 6, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Jiangsu Newvalue Medical Products Co., Ltd. has at least 1 other 510(k) clearance on record.