510(k) K212698

Plus Medical Isolation Gown Level 3 by Foshan Nanhai Plus Medical Co, Ltd. — Product Code FYC

K212698 is an FDA 510(k) premarket notification submitted by Foshan Nanhai Plus Medical Co, Ltd. for the device "Plus Medical Isolation Gown Level 3". The FDA issued a decision of Substantially Equivalent on March 2, 2022. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Foshan Nanhai Plus Medical Co, Ltd. has at least 7 other 510(k) clearances on record.