510(k) K222266

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) by Jingzhou Haixin Green Cross Medical Products Co., Ltd. — Product Code FXX

K222266 is an FDA 510(k) premarket notification submitted by Jingzhou Haixin Green Cross Medical Products Co., Ltd. for the device "Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)". The FDA issued a decision of Substantially Equivalent on Sep 26, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Jingzhou Haixin Green Cross Medical Products Co., Ltd. has 1 other 510(k) clearance on record.