Versaflex - BVM Resuscitator Bag BAG-VALVE-MASK (BVM) MANUFACTURER R E S U S C I T A T O R B A G • Compatible gamma sterilization process • Achieve desired elastomeric properties • PVC-free formulation • FDA, ISO 10993, USP VI compliant • Repeatable injection molding process • Complemented customer expertise with technical support in material selection, part & tool design, and process development • Customized TPE offered customer an alternative to vinyl without sacrificing performance • Improved process efficiency and overall system costs through injection molding method Customized Versaflex™ TPE KEY REQUIREMENTS WHY AVIENT?

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?

Versaflex™ & Versalloy™ Specialty Engineered Materials Thermoplastic Elastomers for Healthcare Applications Delivering specialized thermoplastic elastomer (TPE) solutions for demanding healthcare applications, Avient has performance-grade materials that are approved for USP VI, ISO 10993-4 and 10993-5. VERSAFLEX™ HC MEDICAL TUBING SERIES • Improve extrusion rates, achieve high service temperature performance or increase clarity in medical tubing • Meet biopharmaceutical needs for weldability and minimize extractables during processing VERSALLOY™ HC SERIES • Obtain better flow in long, thin paths and lower shrink rates versus typical TPVs with our alloys, made with Santoprene™ TPV • Color easily and obtain a smooth tactile feel VERSAFLEX™ HC GASKETS & STOPPERS SERIES • Achieve no coring, good puncture and resealability in static stoppers • Meet low COF and low stiction requirements in dynamic seals CL E SERIES • Increase clarity and flexibility in bags, bottles and films • Mitigate risk with plasticizer-free formulations for film extrusion • Deliver excellent odor & O2 barrier performance for film extrusion INDUSTRY BULLETIN TPE HEALTHCARE PRODUCT SELECTOR GUIDE Versaflex™ HC MT Series Versaflex™ HC MT222 Clear 66A 0.88 14 - 334 2.30 629 4.34 898 6.19 430 220 36 ✔ ✔ High clarity, without plasticizersVersaflex™ HC MT224 Clear 75A 0.89 19 - 468 3.23 773 5.33 1360 9.40 530 321 56 ✔ ✔ Versaflex™ HC MT226 Clear 84A 0.88 20 - 606 4.17 885 6.10 1600 11.00 600 433 76 ✔ ✔ Versaflex™ HC MT317 Clear 68A 0.89 17 69 450 3.10 660 4.55 870 6.00 470 221 39 ✔ ✔ Very high service temperature Versaflex™ HC BT218 Natural 67A 0.89 19 69 381 2.60 683 4.70 1186 8.20 608 - - ✔ ✔ Weldable, kink resistant Versaflex™ HC Gaskets & Stoppers Series Versaflex™ HC 2110-35N Natural 34A 0.90 19 47 145 1.00 261 1.80 400 2.76 620 97 17 ✔ ✔ Good resealing Versaflex™ HC 2110-43N Natural 43A 0.98 12 46 134 0.92 368 2.54 723 4.98 710 - - ✔ ✔ Good compression set Versaflex™ HC 2110-57B Black 59A 1.01 20 37 369 2.54 558 3.85 537 3.70 350 147 26 ✔ ✔ Low stiction Versaflex™ CL E Series Versaflex™ CL E85 Clear 84A 0.90 20 72 752 5.18 1160 8.00 1550 10.70 450 433 76 ✔ ✔ High clarity, without plasticizers; E95 also offers excellent odor & O2 barrier Versaflex™ CL E90 Clear 90A 0.90 27 73 1000 6.89 1230 8.50 1830 12.60 57 - - ✔ ✔ Versaflex™ CL E95 Clear 95A 0.90 38 71 1680 11.60 1730 11.90 2500 17.20 580 720 126 ✔ ✔ Versaflex™ HC 3810 Series Versaflex™ HC 3810-20N Natural 20A 0.88 16 54 123 0.80 185 1.30 342 2.40 650 - - ✔ - Formulated without animal derivatives, excellent colorability, translucent Versaflex™ HC 3810-30N Natural 30A 0.89 18 58 170 1.20 245 1.70 459 3.20 680 - - ✔ - Versaflex™ HC 3810-40N Natural 40A 0.88 19 59 191 1.30 275 1.90 506 3.50 670 - - ✔ - Versaflex™ HC 3810-50N Natural 50A 0.89 21 61 264 1.80 366 2.50 699 4.80 690 - - ✔ - Versaflex™ HC 3810-60N Natural 60A 0.88 24 65 459 3.20 594 4.10 790 5.40 510 - - ✔ - Versaflex™ HC 3810-70N Natural 70A 0.88 28 67 535 3.70 684 4.70 1000 6.90 570 - - ✔ - Versaflex™ HC 3810-80N Natural 80A 0.88 30 67 689 4.80 869 6.00 1390 9.60 620 - - ✔ - Versaflex™ HC 3810-90N Natural 90A 0.88 27 89 1087 7.50 1350 9.30 1890 13.00 570 - - ✔ - Versalloy™ HC 9210 Series Versalloy™ HC 9210-45N Natural 45A 0.89 19 39 160 1.10 320 2.20 484 3.33 480 100 18 - ✔ Smooth surface aestheticsVersalloy™ HC 9210-55N Natural 53A 0.89 20 44 208 1.44 335 2.31 580 4.00 610 120 21 - ✔ Versalloy™ HC 9210-70N Natural 70A 0.89 23 53 356 2.45 510 3.52 780 5.38 590 180 32 - ✔ Versalloy™ HC 9220 Series Versalloy™ HC 9220-70 Natural 70A 0.95 17 51 453 3.12 - - 643 4.43 265 208 36 ✔ ✔ ExtrudableVersalloy™ HC 9220-80 Natural 80A 0.94 18 59 553 3.67 777 5.36 945 6.52 415 208 36 ✔ ✔ Versalloy™ HC 9220-90 Natural 90A 0.94 25 55 1030 8.13 1350 9.33 1945 13.45 620 400 70 ✔ ✔ Standard Healthcare Grades Versaflex™ G2705N Natural 60A 0.88 - - - - 528 3.64 670 4.62 470 - - ✔ ✔ Natural, high strength Versaflex™ CL 2242 Clear 43A 0.89 23 - 152 1.05 294 2.02 731 5.00 780 124 22 ✔ ✔ High clarity, boilable Versaflex™ CL 2250 Clear 50A 0.89 20 - 220 1.52 337 2.32 827 5.70 770 140 25 ✔ ✔ Versaflex™ OM Series Versaflex™ OM 1040X Natural 42A 0.92 22 - 180 1.24 301 2.08 504 3.47 580 100 18 ✔ ✔ ABS/PC overmoldVersaflex™ OM 3060 Clear 59A 0.90 33 - 420 2.90 360 2.48 500 3.45 480 180 32 ✔ ✔ Color Hardness Specific Gravity Compression Set @ 23°C Compression Set @ 100°C 100% Modulus 300% Modulus Tensile Strength Elongation Tear Strength ISO 10993 USP VI Special Characteristics ASTM Shore A ASTM/ISO ASTM % ASTM % ASTM psi Mpa ASTM psi Mpa ASTM psi ISO Mpa ASTM % ASTM pll ISO kN/m GENERAL PROPERTIES TENSILE PROPERTIES OTHER For further information on specific grades, review technical data sheets.

Homepage // News Center // PolyOne Specialty Coatings and Inks Kennesaw, GA Plant Achieves ISO 9001-2008 Certification CLEVELAND – PolyOne today announced that its Specialty Coating and Inks plant in Kennesaw, GA recently achieved ISO 9001-2008 certification. Kennesaw is the third plant in our Specialty Coatings business to achieve ISO 9001-2008 certification, joining our Mountain Top, PA and Long Beach, CA facilities,” Bindner said.

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.

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 OnColor™ HC Plus, MEVOPUR® 5.

可根据要求提供多种定制化 颜色解决方案 根据ISO 13485/GMP质量体系生产，并拥有变 更控制管理 原材料红外光谱分析和常规批次检测 根据ISO 10993第18部分对正己烷、异丙醇及 水中的可萃取性进行评估 法规支持 原材料根据ISO 10993-1和USP第、 章（VI类）对原材料进行生物评估的预测试 向FDA提交所有标准颜色的DMF/MAF文件 应用 医疗器械，如导管和连接器、注射器针头及无 针连接器 与皮肤接触设备，如可穿戴设备或医疗器械的 柔软触感表面 MEVOPUR LQ 配方可用于要求严苛的应用，包 括： MEVOPUR™-LQ 不透明红（PMS198C） 产品编号：FZ3M415008 MEVOPUR™-LQ 透明红 产品编号：FZ3M415009 MEVOPUR™-LQ 不透明蓝（PMS292C） 产品编号：FZ5M415008 MEVOPUR™-LQ 透明蓝 产品编号：FZ5M415009 MEVOPUR™-LQ 不透明黄（PMS1205C） 产品编号：FZ1M415005 MEVOPUR™-LQ 透明黄 产品编号：FZ1M415006 MEVOPUR™-LQ 不透明绿（PMS346C） 产品编号：FZ6M415008 MEVOPUR™-LQ 透明绿 产品编号：FZ6M415009 MEVOPUR™-LQ 不透明紫（PMS2655C） 产品编号：FZ4M415003 MEVOPUR™-LQ 透明紫 产品编号：FZ4M415004 定制化选择 也可以根据您的需求 定制颜色， 请联系我们。 埃万特的产品不为以下目的或用途而设计，也不会宣传或预期用于以下目的或用途： (a) 被美国食品药品监督管理局（FDA）或国际标准化组织（ISO）归类为“植入”类器械的医疗器械；或美国药典（USP）或ISO标准定义的“永久”使用器械；或 (b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械；或者 (c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。

Versaflex HC - Syringe Plunger - Spanish FABRICANTE DE JERINGAS É M B O L O D E J E R I N G A D E S E C H A B L E • Cumplir con las normas USP VI e ISO 10993-4,5 • Esterilización con gamma y EtO • Rendimiento de sellado a largo plazo • Bajo coeficiente de fricción (COF) • Rendimiento uniforme en jeringas de diferentes diámetros • Ofreció una solución formulada que cumple con los requerimientos rigurosos de una aplicación médica • Mejoró la continuidad del suministro global • Aumentó la eficiencia del proceso al sustituir el material termoestable anterior con un TPE Versaflex™ HC 2110-57B REQUERIMIENTOS CLAVE ¿POR QUÉ AVIENT?

Also available are OnColor HC Plus Colorants, certified to meet or exceed USP Class VI and ISO 10993 bio-compatibility requirements. KEY CHARACTERISTICS • Polymer colorants formulated specifically for healthcare product applications • Meets and exceeds various material performance requirements including FDA 21 CFR, ISO 10993 and USP Class VI • HC Plus colorants certified for bio-compatibility • Available as pre-color, concentrate, masterbatch or Smartbatch™ combined colorant/additive solution • Wide range of colors, striking special effects and custom color matching MARKETS AND APPLICATIONS OnColor™ HC and HC Plus Colorants are an excellent choice for medical devices and parts, pharmaceutical or cosmetic packaging, and many other healthcare related polymer applications.

APPLICATIONS • Medical devices • Drug delivery devices • Labware KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number level, reducing risk of change 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* * FDA/EU compliance information available upon request Copyright © 2023, Avient Corporation.