PFX Flex™ liners become the first medical device components to earn Intertek’s PFAS-free certification.

Orangeburg, S.C. – [July 29, 2026] – Zeus, a global leader in advanced polymer solutions and catheter manufacturing, today announced that PFX Flex™ Sub-Lite-Wall™ liners have become the first medical device components to earn PFAS-free certification from Intertek, a leading Total Quality Assurance provider to industries worldwide.

“For nearly sixty years, Zeus has built its reputation on fluoropolymer innovation,” said Paddy O’Brien, Chief Executive Officer at Zeus. “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. PFAS-Free is Intertek’s certification designation for products that meet these thresholds. The certification covers the PFX Flex™ catheter liner portfolio, manufactured over either PEEK or silver-plated copper (SPC) mandrels.

As interest in non-fluorinated materials grows, manufacturers are evaluating a widening field of options, and the PFAS-free claims attached to those options vary widely in how they are defined and substantiated. Independent third-party validation brings greater consistency and transparency to those evaluations, helping establish a common benchmark for PFAS-free claims.

“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.” said Faye Ricker, Sustainability Certification Manager at Intertek. “We’re pleased to recognize PFX Flex as the first medical device liner to earn this certification.”

Introduced in January 2026, PFX Flex™ is engineered to deliver the performance catheter manufacturers expect from PTFE in a non-fluorinated construction.¹ The liner combines PTFE-like lubricity, flexibility, direct covalent bond strength, exceptional abrasion resistance, and compatibility with multiple sterilization methods,² giving manufacturers greater design flexibility without compromising the performance characteristics that matter most.

“The goal wasn’t just to create a PTFE-alternative catheter liner,” said Suresh Sainath, Chief Technology Officer at Zeus. “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.”

In medical devices, a material chosen today may not reach a patient for years, even as PFAS regulations evolve across global markets. Our customers desire additional confidence that the materials they select now will still meet tomorrow’s standards.

“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,” said Jim O’Connell, Chief Commercial Officer at Zeus. “Our aim is to give them options that perform, backed by testing and certification, no matter where regulations may land.”

QUICK FACTS

• Intertek certified PFX Flex™ Sub-Lite-Wall™ liners as meeting its criteria for PFAS-free certification.
• Certification conformance criteria: total organic fluorine below 20 ppm; targeted PFAS below 25 ppb.
• Scope of certification: applies to the PFX Flex™ catheter liner portfolio over PEEK or silver-plated copper (SPC) mandrels.

PFX Flex™ Sub-Lite-Wall™ was introduced in January 2026 as the first product in the PFX™ platform. To learn more about PFX Flex™ Sub-Lite-Wall™, visit https://www.zeusinc.com/pfx/flex/.

Notes

¹ PFX Flex™ liners are made using a non-fluorinated polymer resin alternative to PTFE and without the intentional addition of any per- or polyfluoroalkyl substances (PFAS). Certified PFAS-free by Intertek Testing Services NA, Inc. to the following conformance criteria: (1) total organic fluorine not exceeding a concentration of 20 mg/kg; as determined with reference to ASTM D7359-23 and (2) targeted PFAS compounds not exceeding an individual concentration of 25 μg/kg as determined with reference to EN 17681-1:2025, EN 17681-2:2022-11, and/or CEN/TS 15968:2010. Current certification valid until June 21, 2027, subject to renewal and extension beyond such date.

² Based on test report, Comparing PFX Flex™ vs. PTFE Catheter Liners. January 2026.

About Zeus

Zeus, headquartered in Orangeburg, South Carolina, is a global leader in advanced polymer solutions that help accelerate innovation across medical, aerospace, energy, automotive, fiber optics, and other demanding markets. Since 1966, Zeus has helped customers solve complex engineering and manufacturing challenges with advanced materials expertise and precision manufacturing. Through its CathX Medical business, Zeus also provides catheter design support and manufacturing services that help customers bring new technologies to market faster. Zeus operates a network of manufacturing facilities across the United States and Ireland. For more information, visit www.zeusinc.com.