510(k) K201470

Disposable Medical Face Mask by Jkh USA, LLC — Product Code FXX

K201470 is an FDA 510(k) premarket notification submitted by Jkh USA, LLC for the device "Disposable Medical Face Mask". The FDA issued a decision of Substantially Equivalent on September 8, 2020. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Jkh USA, LLC has at least 8 other 510(k) clearances on record.