What are medical grade TPEs? Additionally, automotive parts and devices made from TPE make vehicles lighter and more fuel efficient. Not surprisingly, the healthcare market has additional regulatory requirements for those creating medical products and devices.

Avient Unveils New Cesa™ Withstand™ Antimicrobial Additives for TPU Film in Medical and Outdoor Applications Avient unveils new grades of Cesa™ Withstand™ to include antimicrobial and antifungal additives for TPU film-laminated products and devices in app

MEDICAL EQUIPMENT MANUFACTURER C L O S E D S Y S T E M D R U G T R A N S F E R D E V I C E • A new material for a seal inside the next generation of closed system drug transfer device • Compliance with stringent regulatory standards: • Biocompatibility to ISO10993 • USP VI compliance • Provided regulatory support services and expertise throughout extensive medical approval process • Provided a custom formulation compliant with the highest healthcare regulatory standards • Enabled material to be manufactured and shipped globally Custom Versalloy™ HC 9220-90 Formulation KEY REQUIREMENTS WHY AVIENT? AVIENT SOLUTION REGULATORY COMPLIANCE LEARN MORE © 2020, All Right Reserved Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012 https://www.avient.com/products/thermoplastic-elastomers/versalloy-thermoplastic-elastomers Medical equipment Manufacturer

Produced under rigorous cGMP and medical manufacturing protocols, the new amber color concentrates are made in three dedicated EN ISO 13485-2016 registered facilities using only medical-grade ingredients. To support customers’ Device Master File submission for healthcare materials, Avient has developed and submitted a type III Drug Master File (FDA) for these colorants.

These USP-compliant colorants are available in liquid silicone rubber (LSR) and high consistency silicone rubber (HCR) forms and can be customized for specific medical uses. These high-quality silicone dispersions excel in sterilization capabilities while maintaining low toxicity, making them ideal for medical applications. KEY CHARACTERISTICS • Meets USP Class VI standards • Biocompatible • Provides lightfastness, chemical resistance, and heat stability • Available in standard single pigment or custom multi-pigment colors • LSR and HCR options available TARGET APPLICATIONS Stan-Tone HC Plus silicone dispersions are suitable for a variety of healthcare applications including: • Catheters and medical tubing • Medical and surgical equipment • Labware and diagnostic devices • Specialty medical devices and wearables Product Code Pigment Type % Pigment (approx.)

These USP-compliant colorants are available in liquid silicone rubber (LSR) and high consistency silicone rubber (HCR) forms and can be customized for specific medical uses. These high-quality silicone dispersions excel in sterilization capabilities while maintaining low toxicity, making them ideal for medical applications. KEY CHARACTERISTICS • Meets USP Class VI standards • Biocompatible • Provides lightfastness, chemical resistance, and heat stability • Available in standard single pigment or custom multi-pigment colors • LSR and HCR options available TARGET APPLICATIONS Stan-Tone HC Plus silicone dispersions are suitable for a variety of healthcare applications including: • Catheters and medical tubing • Medical and surgical equipment • Labware and diagnostic devices • Specialty medical devices and wearables Product Code Pigment Type % Pigment (approx.)

Glucose Monitoring App Snapshot draft MEDICAL DEVICE OEM C O N T I N U O U S G L U C O S E M O N I T O R I N G S Y S T E M • Adapt to strict processing requirements of a secondary operation put in place to manufacture a new device model • Meet material size and thickness requirements while achieving desired color target • Overcome material unpredictability and sensitivity to heat, light and moisture • Minimize impact of supply chain instability and changes • Offered support for processing under low pressure conditions and at every stage of manufacturing • Performed extensive R&D work to consistently deliver the customer’s color target of a hard-to-achieve light gray • Effectively addressed all material challenges and sensitivities • Provided regular ‘summaries of understanding’ to keep up with changing forecasts and ordering patterns Mevopur™ Pre-color Formulation KEY REQUIREMENTS WHY AVIENT?

240625-2017-AQ-RGC-NA-PS Initial certification date: 14 September 2017 Valid: 08 February 2025 – 07 February 2028 This is to certify that the management system of PolyOne-Shanghai, China 88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode: 91310000607342402D) has been found to conform to the Quality Management System standard: ISO 13485:2016 This certificate is valid for the following scope: Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates Used for the Plastic Parts of Medical Devices http://www.dnv.com

The last thing users should notice is the device itself. It’s important to ensure the device performs well from the first time to the last. Virtual Reality Devices Our materials provide comfort, durability and appeal for VR devices used in the following enterprise and commercial applications.

Compartment Cover for Medical Device Medical Devices & Equipment Medical Device Trays and Kits