Zeus announced on July 30 that its PFX Flex Sub-Lite-Wall liners have become the first medical device components to earn PFAS-free certification from Intertek, a provider of Total Quality Assurance services. The certification applies to Zeus's PFX Flex catheter liner portfolio, which is manufactured over either PEEK or silver-plated copper mandrels.
Paddy O’Brien, Chief Executive Officer at Zeus, said, “For nearly sixty years, Zeus has built its reputation on fluoropolymer innovation. As the medical device industry evaluates new material alternatives, we believe customers deserve objective, independent validation of the claims behind those technologies. That’s why third-party certification matters. It gives engineers confidence that they can make critical material decisions based on verified data.”
Intertek’s certification confirms that PFX Flex liners contain total organic fluorine levels below 20 ppm and targeted PFAS below 25 ppb, meeting Intertek’s published criteria for PFAS-free certification. Faye Ricker, Sustainability Certification Manager at Intertek, said, “Our PFAS-Free Certification combines Total Organic Fluorine and targeted PFAS testing with material documentation and ongoing oversight, giving manufacturers and their customers confidence that PFAS-free claims are supported by a rigorous, science-based evaluation. We’re pleased to recognize PFX Flex as the first medical device liner to earn this certification.”
Zeus stated that as interest in non-fluorinated materials grows among manufacturers evaluating new options for medical devices, independent third-party validation brings greater consistency and transparency to evaluations of PFAS-free claims.
Introduced in January 2026, Zeus says PFX Flex is engineered to deliver performance comparable to PTFE but in a non-fluorinated construction. According to the company’s test reports, it offers lubricity, flexibility, direct covalent bond strength, abrasion resistance, and compatibility with multiple sterilisation methods.
Suresh Sainath, Chief Technology Officer at Zeus, said, “The goal wasn’t just to create a PTFE-alternative catheter liner. The challenge was finding a non-fluorinated material capable of matching the performance that has made PTFE the gold standard for catheter liners for decades. That required years of research and development, and independent verification through Intertek provides an objective validation of the technology we’ve developed.” Jim O’Connell, Chief Commercial Officer at Zeus, added, “Even if there’s no regulatory ban on the use of PFAS-based materials in medical devices today, our customers are already evaluating alternatives rather than waiting for one. Our aim is to give them options that perform backed by testing and certification no matter where regulations may land.”
