510(k) K202341

Disposable Surgical Mask by Shanghai Jianzhong Medical Packaging Co., Ltd. — Product Code FXX

K202341 is an FDA 510(k) premarket notification submitted by Shanghai Jianzhong Medical Packaging Co., Ltd. for the device "Disposable Surgical Mask". The FDA issued a decision of Substantially Equivalent on February 12, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Shanghai Jianzhong Medical Packaging Co., Ltd. has at least 2 other 510(k) clearances on record.