Zhejiang Lanhine Medical Products Ltd.

Zhejiang Lanhine Medical Products Ltd. specializes in single-use public face masks, which are designed for general respiratory protection in non-medical settings. These devices are intended for short-term use to help reduce the spread of airborne particles like droplets and aerosols.

The company is based in the United States, though its manufacturing may originate from Zhejiang, China, as implied by its name. The U.S. presence is relevant for regulatory compliance and distribution in North America.

The company’s products are classified as FDA-regulated Class II medical devices. This classification typically applies to devices with moderate risk, requiring special controls to ensure safety and effectiveness, such as face masks that protect against airborne contaminants.

Yes, the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices for regulatory, clinical, and market surveillance purposes, ensuring traceability and compliance.