510(k) K210229

Sterile Auto-Disable Syringes with/without Needle for Single Use by Zhejiang Kangkang Medical-Devices Co., Ltd. — Product Code MEG

K210229 is an FDA 510(k) premarket notification submitted by Zhejiang Kangkang Medical-Devices Co., Ltd. for the device "Sterile Auto-Disable Syringes with/without Needle for Single Use". The FDA issued a decision of Substantially Equivalent on February 15, 2022. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Zhejiang Kangkang Medical-Devices Co., Ltd. has at least 3 other 510(k) clearances on record.