510(k) K201691

Single-Use Surgical Mask With Ear Loop by Qiqihar Hengxin Medical Supplies, Ltd. — Product Code FXX

K201691 is an FDA 510(k) premarket notification submitted by Qiqihar Hengxin Medical Supplies, Ltd. for the device "Single-Use Surgical Mask With Ear Loop". The FDA issued a decision of Substantially Equivalent on Sep 17, 2020. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Qiqihar Hengxin Medical Supplies, Ltd. has 1 other 510(k) clearance on record.