AVIENT SOLUTION MEDICAL DEVICE MANUFACTURER C O M P R E S S I O N C O N T R O L L E R H O U S I N G G R I P • Good adhesion to PCTG • Comfortable grip combined with ergonomics • Medical regulation compliance • Provided a medical-grade TPE with excellent bonding to PCTG and good chemical resistance • Improved ergonomics and aesthetics with a soft- touch material • Met medical regulation compliance: FDA21 CFR 177.2600 • Delivered good colorability to ensure a stable esthetic KEY REQUIREMENTS OVERMOLDING + REGULATORY SUPPORT LEARN MORE Versollan Thermoplastic Elastomers Copyright © 2024, Avient Corporation. All Rights Reserved. https://www.avient.com/products/thermoplastic-elastomers/versollan-thermoplastic-elastomers Slide 1: Medical Device manufacturer

Normative basis EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. Ltd. 30, Hsing Pang Road 33068 Taoyuan Taiwan Design and manufacture of colour and additive concentrates and specialty compounds for the Healthcare and Medical device market. Lewiston, ME, 04240 United States of America Design and manufacture of colour and additive concentrates and specialty compounds for the Healthcare and Medical device market.

APPLICATION BULLETIN Resilience™ HC for Medical Device Housings Offering Improved Resistance to Hospital Disinfectants EFFECT ON POLYMER HOUSINGS FOR MEDICAL DEVICES Unfortunately, the increased disinfection practices among healthcare providers have another effect. Rigid polymers typically used to make housings for medical devices are failing to resist these chemicals. To cope with this challenge, hospitals are cleaning medical devices more frequently and with harsher disinfectants than ever before.

PowerPoint Presentation MEDICAL DEVICE MANUFACTURER O S T O M Y B A G S E A L S • Comply with ISO 10993 and FDA Class II medical device regulations • Offer Good sealing performance • Provide technical supports for processing recommendations • Deliver a high compression set materials to improve comfort • Provided a medical-grade TPE to help the customer meet necessary regulatory specifications and gain market share • Provided technical support during design and the manufacturing process for EVA bonding • Delivered soft-touch feel and excellent sealing performance Versaflex HC Thermoplastic Elastomers - G2705 Formulation KEY REQUIREMENTS WHY AVIENT? All Rights Reserved. https://www.avient.com/products/thermoplastic-elastomers/versaflex-hc-thermoplastic-elastomers Slide 1: MEDICAL Device manufacturer

Avient products have not been designed for nor are they promoted or intended for use in: (a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under US Pharmacopoeia (USP) or ISO standards; or (b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or (c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended. Without limiting the generality of this statement, Avient products shall not be used in any medical device application intended for: (1) exposure to human tissue or body fluids for 30 days or greater; (2) “plastic” (cosmetic or reconstructive) surgery use; (3) reproductive implants or any birth control device; or (4) any critical component in a permanently (greater than 30 days) implanted medical device that supports or sustains human life. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device, including the suitability of all raw materials and components used for its manufacture, and with all applicable laws and regulations. 1.844.4AVIENT www.avient.com

Through its Complēt® product lines and design capabilities, the company serves global customers in a wide-range of demanding applications, including medical devices, robots and drones, marine, and outdoor high performance equipment. 

Enhanced and developed to meet specific requirements, Stan-Tone™ RBX dispersion technologies can be effectively used for a variety of applications, including industrial goods, automotive mats, rubber flooring, sponge rubber, wire and cable applications, and medical equipment.

Portfolio of available dispersion colorants and additives for medical applications

Antimicrobial corrosion and chemical resistant formulations to solve your medical application challenges

Standard and custom color solutions for today’s complex medical applications