Shanghai Ganghai Model Giko 1400

K063334 is the FDA 510(k) clearance record for SHANGHAI GANGHAI MODEL GIKO 1400, a class II device, cleared for Shanghai Gangkai Purifying Products Co., Ltd. on 2006-12-08 under FDA product code MSH (Respirator, Surgical). FDA's definition for product code MSH reads: "A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific...". FDA records list one 510(k) clearance for Shanghai Gangkai Purifying Products Co., Ltd. As of 2026-09-10, FDA records show no recalls naming K063334.