Medalist® Thermoplastic Elastomers meet FDA and REACH SVHC Standards.
Press Release Summary:
Thermoplastic Elastomers are offered in Medalist® 50100 Series and Medalist® 10100 Series gels families. 50100 Series are available in Shore A hardness of 58, 68 and 73 and are used in respiratory therapy oxygen masks. 10100 Series are designed in clear 8 Shore A compound and translucent compound with 18 Shore A hardness and ensures gas-tight fit to the patients face. Units are free from DEHP and other phthalates, BPA, and latex.
Original Press Release:
Medical TPEs for Face Masks and Cushions Provide Performance and Cost Advantages Over PVC and Silicones
Flexible Masks Made of Clear Medalist® 50100 Series TPEs Retain Their Shape in Packing and Storage; Medalist® 10100 Series Gels Provide Secure Cushions for Rigid PP Masks
Two new families of medical-grade thermoplastic elastomers (TPEs) for injection molded face masks include a deformation-resistant series for flexible masks and a series of gels that provide a gas-tight cushion for rigid ones molded from polypropylene. Teknor Apex Company will introduce the compounds at MD&M West (Booth 2014).
- Medalist® 50100 Series TPEs for flexible masks are more deformation-resistant than PVC and, as thermoplastics, provide a more economical alternative to silicones. In respiratory therapy oxygen masks, the Medalist TPEs are flexible enough to provide a comfortable fit on the face yet retain their shape during packaging and storage, without need for inserts. Their PVC-like transparency facilitates patient monitoring. Medalist 50100 Series compounds are available in Shore A hardnesses of 58, 68, and 73.
- Medalist® 10100 Series TPE gels for rigid-mask cushions bond to polypropylene in insert or two-shot molding, providing a less expensive alternative to the traditional air-filled PVC “balloon” cushions that must be glued onto the rigid component. The super-soft cushion conforms to the patient’s face to ensure a gas-tight fit that is more secure than the PVC cushion and has a lower profile on the face. Grades in the series include a clear 8 Shore A compound and a translucent one with 18 Shore A hardness. Pre-colored compounds are available to enable device manufacturers to differentiate their product offerings.
"More and more, medical device OEMs are choosing Medalist as an alternative to both PVC and silicone for face masks,” said Ross van Royen, senior market manager of regulated products for the TPE Division of Teknor Apex. “In flexible mask applications, the Medalist MD-50100 series provides the same clarity and flexibility as PVC, but with better deformation resistance, allowing for improved packaging and storage. These materials can also be used as more economical alternatives to silicone face masks."
Teknor Apex produces Medalist compounds in ISO-13485 facilities in the USA and Singapore. The new materials comply with FDA requirements for food-grade ingredients, ISO 10993-5 standards for biocompatibility, and REACH SVHC directives. They are free of DEHP and other phthalates, BPA, and latex. Standard grades are ADM-free.
About Teknor Apex. Teknor Apex Company, a privately held firm founded in 1924, is one of the world’s leading custom compounders of plastics. Teknor Apex produces flexible and rigid vinyl, thermoplastic elastomers, nylons, color masterbatches, specialty chemicals, and hoses. The company is headquartered in Pawtucket, RI, U.S.A. and operates thirteen manufacturing facilities worldwide in the United States, Belgium, Germany, China, and Singapore. To learn more visit: www.teknorapex.com.
The Thermoplastic Elastomer Division of Teknor Apex Company offers the broadest portfolio of TPE compounds available from a single source. The division compounds TPEs at eight locations in the U.S., Europe, and Asia under the brands: Elexar® (electrical and electronics applications), Medalist® (medical devices), Monprene® (consumer and industrial products), and Sarlink® (transportation).
