KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Available as additive concentrates, ready-to-use additive formulations or ready-to-use additive/ colorant formulations for different polymers REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request; exceptions may occur Healthcare use limitations apply—see below.

ISO 14001 certifications follow intensive environmental audits of organizations, conducted by third-party ISO representatives. At present, multiple Avient facilities hold ISO 14001 Certification. Global ISO Certificate Library

DIN EN ISO 105-B06 DIN EN ISO 105-C04 DIN EN ISO 105-P02 DIN EN ISO 105-X12

Yes, as required by the standard(s) Does your company have documented procedures and controls in place for the selection, approval, and monitoring of external Yes, supplier selection conforms to IATF & ISO 13485 requirements. IATF and ISO 13485 managed within ETQ Reliance. ISO sites perform as needed; IATF 16949/ISO 13485 sites perform Gage R&R per standard requirements 10.4 Manufacturing, Production & Process Controls Are all manufacturing processes covered with formally written SOP's?

GLOBAL ISO 13485 MANUFACTURING FOOTPRINT Avient’s certified sites are located on three continents and offer manufacturing support, project transfer and back-up supply to reduce supply chain risk. COMPREHENSIVE REGULATORY TESTING AND DOCUMENTATION Raw materials tested to: • ISO 10993-1 and USP , (biological evaluation) • European Pharmacopeia 3.1.3/3.1.5 (polyolefin —materials used for the manufacture of containers) • USP (polyethylene—plastic materials of construction) • ICH Q3D (elemental impurities) We provide Drug Master File (Type III) documentation and other supporting regulatory declarations that are relevant for the application. They are manufactured at ISO 13485 certified sites with bio-compatible raw materials and documented change control.

Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 46154 Validity 12.01.2022 – 11.01.2025 Issue 12.01.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland F.

Customized color solutions are available on request • Production under ISO 13485 / GMP quality system with change control management • Fingerprinting of raw materials and routine batch testing • Extractability evaluated in hexane, isopropanol, and water according to ISO 10993 part 18 REGULATORY SUPPORT • Raw materials are pre-tested to biologically- evaluated raw materials using ISO 10993-1 and USP chapters , Class VI • DMF/MAF documentation filed with the FDA for all standard colors APPLICATIONS MEVOPUR LQ formulations can be applied in demanding applications including: • Medical devices such as catheter tubing & connectors, syringe tips, and needleless connectors • Skin contact devices such as wearables or soft-touch surfaces of medical devices PRODUCT BULLETIN MEVOPUR™-LQ YELLOW (PMS1205C) Product Code FZ1M415005 MEVOPUR™-LQ TRANS YELLOW Product Code FZ1M415006 MEVOPUR™-LQ BLUE (PMS292C) Product Code FZ5M415008 MEVOPUR™-LQ TRANS BLUE Product Code FZ5M415009 MEVOPUR™-LQ RED (PMS198C) Product Code FZ3M415008 MEVOPUR™-LQ TRANS RED Product Code FZ3M415009 MEVOPUR™-LQ GREEN (PMS346C) Product Code FZ6M415008 MEVOPUR™-LQ TRANS GREEN Product Code FZ6M415009 MEVOPUR™-LQ VIOLET (PMS2655C) Product Code FZ4M415003 MEVOPUR™-LQ TRANS VIOLET Product Code FZ4M415004 CUSTOM-MADE Individual options Customized colors are also available to meet your needs, please contact us. 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.

DIAGNOSTICS MANUFACTURER C O V I D - 1 9 C O N T A I N M E N T T U B E S C R E W C A P S • Wide range of durometers with consistent raw materials • Processing consistencies across the durometer ranges for an easy transition between materials • Materials formulated without animal derivatives at a competitive cost • Offered a comprehensive range of solutions to accommodate specific application demands such as barrier, flexibility, and sealing performance • Provided materials manufactured in an ISO 13485 certified facility • Delivered a series of medical-grade TPEs that could be extruded and injection molded Versaflex™ HC 3810 Thermoplastic Elastomers KEY REQUIREMENTS WHY AVIENT?

Pigments and eye-catching special effects • Prompt, precise and custom color matching • Biocompatible functional additives • FDA CFR 21, USP VI, ISO 10993-X, and/or USP 661-X • ISO 13485 facilities Avient Corporation 5 4. Requirements: Skin contact colorant certified for ISO 10993 biocompatibility Solution: OnColor™ HC Plus, MEVOPUR® 5.

KEY CHARACTERISTICS • Available for polyethylene, polypropylene, ABS, polycarbonate and styrenics • Bio-content of resin carrier varies from 70% to 100% depending on polymer—calculated to ASTM D6866 standard • Manufactured at four ISO 13485 certified sites, providing global consistency and security of supply • Documented change control beyond CAS number, reducing risk of change • Drop-in solutions that can be processed like fossil-based grades on common injection molding and extrusion machines • Can be provided as ready-to-use pre-colored or additive formulation REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP and (incl. class VI) - European Pharmacopeia, monograph 3.1.3/ 3.1.5 (polyolefin packaging materials) - USP (polyethylene) - Elemental impurities as per ICH Q3D • Registered Drug Master File (Type III) and/or Device Master File • Food contact according to US FDA and APPLICATION BULLETIN Sustainability Spotlight Bio-polymers Healthcare use limitations apply—see below.