US and China Manufacturing

Serving Global Clients with US and China Manufacturing

We are proud to be the first U.S.-based medical silicone molding operation to be established and validated in China, with a strong record of quality shipments since 2011. Our facility is located in one of the premier industrial developments in China, with a robust infrastructure and room for expansion.

Whether a U.S.-based client chooses to manufacture in China, the U.S. or both facilities, our U.S. staff members oversee each project, serving as liaison to our managers in China as required. All projects, whether manufactured in the U.S. or China, are quoted in U.S. dollars to avoid currency exchange issues.

  • Dual Capabilities - FMI maintains dual tooling and molds and advanced manufacturing systems in both facilities to ensure quality and availability.
  • Security - We safeguard our clients' proprietary data and intellectual property on a secured hard drive, with limited, authorized access.
  • Competitive Costs - Our China operation combines lower-cost, highly skilled labor with the same advanced molding practices as the U.S., providing an attractive offshore option, particularly for companies that ship to Asia and the Pacific.
  • Wholly Foreign Owned Enterprise (WFOE) in China - FMI does business in China as a WFOE, which offers such advantages as the ability to operate without a Chinese partner, protection of technology and intellectual property, and no special requirements for import/export licensing.


Certifications: ISO 13485


  • Clean room manufacturing for ISO Classes 5, 6 and 7 (100, 1000, and 10,000)
  • 20,000 square-foot manufacturing, warehouse and distribution facility
  • Special silicone/desiccant mixing and molding technology, automated assembly, automated measurement system 

FMI China 

Certifications:  ISO 9001:2008; ISO 13485


  • Clean room manufacturing for ISO Class 7 (10,000)
  • 6,000 square-foot manufacturing, warehouse and distribution facility
  • Automated measurement systems
  • Secured information systems and paperless operations to protect intellectual property
  • Skilled labor force with managers fluent in English
  • Commitment to international safety standards
  • Ability to import U.S. medical-grade silicone as needed
  • Expertise in import/export requirements, inventory management, and logistics worldwide
China Manufacturing