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January 25, 2021 02:16 PM

Flexan receives FDA registration for Suzhou facility

Rubber & Plastics News Staff
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    Flexan Suzhou 1_i.jpg
    Flexan
    Flexan's Suzhou, China, manufacturing facility has been registered by the Food and Drug Administration for class II and III medical device production.

    Lincolnshire, Ill. — From a flexible sander made for Sears Roebuck in 1946 to intricate medical devices for niche markets today, Flexan LLC has experienced success across a range of molded goods spaces.

    That growth continued recently with the company's Suzhou, China, manufacturing facility becoming registered by the Food and Drug Administration for class II and III medical device production. Flexan opened the plant in 2004.

    "This registration represents another effort by Flexan to meet the needs of our global customer base and support their desire for high-quality, cost-competitive medical devices," said Mike Huiras, vice president of sales and marketing for Flexan. "We are confident that our dedicated team in Suzhou is prepared to support our first full device production program, along with additional new business we expect to support in Suzhou in the future. Our experience operating in China for nearly 2 decades has prepared us for this next stage in our growth as a global services provider."

    Flexan, which works in silicone, TPEs and other specialty elastomers, also recently registered its first finished device, to begin production in Suzhou this year.

    Flexan provides a range of services, from molding and extrusion to packaging and assembly. Flexan has the ability to mold in tight and specific geometries, and can bond rubber to metal and other substrates. The company supports product design and development as well.

    Established in 1946 when the Lilleberg brothers responded to a request from Sears Roebuck & Co. to improve their circular sanding tool at the time, Flexan developed a rubber pad that could be molded over the metal sanding pad — producing the Sears "flexible" sander.

    The medical division was established in 1989. In addition to the Suzhou facility, Flexan maintains facilities in Salt Lake City, with its headquarters in Lincolnshire, Ill.

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