510(k) K213535

Sterile Safety Hypodermic Needles for Single Use by Zhejiang Kangkang Medical-Devices Co., Ltd. — Product Code FMI

K213535 is an FDA 510(k) premarket notification submitted by Zhejiang Kangkang Medical-Devices Co., Ltd. for the device "Sterile Safety Hypodermic Needles for Single Use". The FDA issued a decision of Substantially Equivalent on May 13, 2022. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Zhejiang Kangkang Medical-Devices Co., Ltd. has at least 3 other 510(k) clearances on record.