Jiangsu Jianyu Health Medical Co., Ltd.

Jiangsu Jianyu Health Medical Co., Ltd. specializes in surgical masks, which are intended for medical and healthcare environments. These devices are designed to create a barrier against airborne contaminants and droplets, helping to protect both patients and healthcare workers during procedures.

The company operates from the United States, though its origins trace back to Jiangsu, China. The US location is where its manufacturing and regulatory submissions, such as 510(k) listings, are managed.

Jiangsu Jianyu Health Medical Co., Ltd.’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class II devices in the US, where manufacturers demonstrate that their products are substantially equivalent to legally marketed predicate devices.

The company’s surgical masks fall under FDA Class II device classification. Class II devices require special controls in addition to general controls to ensure their safety and effectiveness, and they are typically submitted via the 510(k) process to demonstrate equivalence to existing approved products.