Foshan Xinbao Technology Co., Ltd.

Foshan Xinbao Technology Co., Ltd. specializes in single-use surgical and medical face masks. These masks are designed for clinical and healthcare environments to provide barrier protection against airborne contaminants and fluid splatter during medical procedures. The company’s portfolio is focused exclusively on this category of disposable personal protective equipment.

Foshan Xinbao Technology Co., Ltd. is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under the Class II category, they must comply with FDA requirements, including pathways like the 510(k) premarket notification process and Unique Device Identification (UDI) registration to ensure traceability and safety standards are met.

Foshan Xinbao Technology Co., Ltd.’s devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries. The 510(k) process demonstrates that the company’s products meet FDA safety and effectiveness requirements by showing substantial equivalence to a legally marketed predicate device. The UDI system ensures accurate identification and tracking of these Class II devices throughout their lifecycle.

Foshan Xinbao Technology Co., Ltd.’s face masks are classified as Class II devices under FDA regulations. This classification applies because they are considered to pose moderate risk and require special controls beyond general controls to ensure their safety and performance. The company must follow FDA-mandated procedures, such as 510(k) submissions and UDI compliance, to demonstrate that their products meet these regulatory requirements.