Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.

Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.

NEEDLE HUB MANUFACTURER N E E D L E H U B C O L O R S • RAL and Pantone® colors available in palette to align with ISO 6009 color standard • Opaque and transparent polypropylene selections available in both masterbatch and ready-to-use precolors • Raw materials pre-tested to ISO 10993 and USP Class VI medical device guidelines • Certified formulations available globally • Provided RAL and Pantone colors as required • Developed custom polypropylene formulations to meet specific opacities • Offered pre-tested raw materials and produced in an ISO 13485 certified site, minimizing risk across the value chain • Provided global formulations transferrable from our three ISO 13485 certified facilities Mevopur™ Healthcare Colors KEY REQUIREMENTS WHY AVIENT?

Certificate - ISO 9001 - Avient Corporation - 337726 - 23521672 (1).pdf

This is to certify that Fiber-Line, LLC 280 Performance Drive SE, Hickory, North Carolina 28602 USA Quality Management System ISO 9001:2015 Manufacture of textile components to cable manufacturers. Certificate No.: CERT-0116814 Original Certification Date: 2010年11月24日 File No.: 1616267 Certification Effective Date: 2021年4月1日 Issue Date: 2021年3月30日 Certificate Expiry Date: 2024年3月31日 ________________________________________________________________________________ ISO 9001 Registered by: QMI-SAI Canada Limited (SAI Global), 20 Carlson Court, Suite 200, Toronto, Ontario M9W 7K6 Canada.

H Y P O D E R M I C N E E D L E M A N U FAC T U R E R N E E D L E H U B , C O V E R A N D S H I E L D • Compliance to ISO 6009 color coding for single use hypodermic needle • Biocompatibility of all component materials • Good mechanical and visual properties after sterilization (e.g. ETO / Gamma radiation) • Facilitated 510(k) submission with formulations registered under Device Master File MAF 1833 • Pre-tested raw materials to biocompatibility ISO10993, US and Eu Pharmacopeia, ICH-Q3D extractable metals • Enhanced stability with gamma stabilizing package • Minimized risk of change with change control beyond CAS number level • Ensured uninterrupted supply from multiple ISO 13485-2016 certified sites • MEVOPURTM ISO 6009 Standard / Customized Solutions KEY REQUIREMENTS WHY AVIENT?

This product selection guide provides detailed information to help you select the Maxxam product that’s right for your application. 4 INJECTION MOLDING POLYPROPYLENE Product Code - - - PP5113 B44 F5134T2-4 PP5130 B63 F5134T4-1 Filler Percentage - % - 13 20 30 40 Tensile Strength Yield psi ASTM D638 5000 4800 4600 4500 MPa ISO 527 33 33 32 31 Tensile Elongation Yield % ASTM D638 6 4 3 2 ISO 527 Break % ASTM D638 60 30 15 10 ISO 527 Flexural Modulus 73°F (23°C) psi ASTM D790 300,000 360,000 400,000 460,000 MPa ISO 178 2300 2450 2900 3300 Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 0.65 0.60 0.55 0.50 kJ/m2 ISO 180 3.50 3.3 3.00 2.75 Heat Deflection 66 psi °F ASTM D648 230 240 260 275 °C ISO 75 110 116 127 135 264 psi °F ASTM D648 130 140 150 175 °C ISO 75 54 60 66 79 Specific Gravity 73°F (23°C) - ASTM D792 0.99 1.04 1.15 1.25 ISO 1183 Linear Shrinkage Range 1/8 in wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0 3.2 mm wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0 Product Code - - - PP6113 A77-SM PP6120 B16-2 PP6130 B11 PP6135 B40-UV Filler Percentage - % - 13 20 30 35 Tensile Strength Yield psi ASTM D638 4350 3500 2600 3700 MPa ISO 527 30 24 18 26 Tensile Elongation Yield % ASTM D638 5 4 7 6 ISO 527 Break % ASTM D638 35 70 150 70 ISO 527 Flexural Modulus 73°F (23°C) psi ASTM D790 290,000 280,000 280,000 390,000 MPa ISO 178 2000 1950 1750 2700 Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 0.7 2.7 4.5 0.65 kJ/m2 ISO 180 4.0 14 24 3.5 Heat Deflection 66 psi °F ASTM D648 239 215 225 250 °C ISO 75 115 102 107 123 264 psi °F ASTM D648 140 125 130 150 °C ISO 75 60 52 54 60 Specific Gravity 73°F (23°C) - ASTM D792 0.99 1.05 1.15 1.18 ISO 1183 Linear Shrinkage Range 1/8 in wall % - 1.1–1.5 .9–1.3 0.7–1.1 0.5–0.9 3.2 mm wall % - 1.1–1.5 .9–1.3 0.7–1.1 0.5–0.9 Maxxam™ Talc-Filled Copolymer Polypropylene • Scratch & mar resistant • UL approved • FDA certifiable • Natural, black or colors • High flow grades • UV stabilized • UL approved • FDA certifiable • Natural, black or colors • High flow grades • UV stabilized • Recycled content Maxxam™ Talc-Filled Homopolymer Polypropylene Offers a moderate level of impact strength and improved stiffness and heat deflection performance. Chemically coupled • Natural or black • High flow grades • Provides heat stabilization • Excellent balance of properties • Natural, black or custom colors Product Code - - - PX5430 B1 PX5435 B1 PX5440 B1 PX5450 B1 Reinforcement Type - - - Glass Glass Glass Glass Reinforcement % - % - 30 35 40 50 Specific Gravity 73°F (23°C) - ISO 1183 1.13 1.18 1.23 1.35 Tensile Strength Yield MPa ISO 527 102 105 113 130 Flexural Modulus 73°F (23°C) MPa ISO 178 6500 8000 9400 11,500 Notched Izod Impact 73°F (23°C) kJ/m2 ISO 180 9.4 9.3 11.0 12.0 Heat Deflection 264 psi °C ISO 75 152 152 153 154 Product Code - - - PP5120 B270-LO MFR g/10 min ISO 1133 12 Tensile Modulus MPa ISO 527 3320 Tensile Stress Yield MPa ISO 527 32 Tensile Elongation Yield % ISO 527 4.6 Tensile Elongation Break % ISO 527 17 Flexural Modulus MPa ISO 178 3000 Charpy Impact 73°F (23°C) kJ/m2 ISO 179/1eU 38 Heat Aging 150°C h VW 44045 700 hr VOC µg/g VDA 278 23.5 Fog µg/g VDA 278 30.5 Carbon Emissions µgC/g VDA 277 18 Odor Grade VDA 270 B3 3 • High flow grades • UV stabilized PROPERTY CONDITION UNITS METHOD PRODUCT EXAMPLES INJECTION MOLDING POLYPROPYLENE PROPERTY CONDITION UNITS METHOD PRODUCT EXAMPLES 10 Maxxam™ Filled & Reinforced Polypropylene A range of melt flows to process well in sheet extrusion, thermoforming, profile extrusion and blow molding operations FDA certifiable • Natural, black or colors • UV stabilized Product Code - - - PE4125 B1 Reinforcement Type - - - Talc Reinforcement % - % - 25 Specific Gravity 73°F (23°C) - ASTM D792 1.15 ISO 1183 Tensile Strength Yield psi ASTM D638 4050 MPa ISO 527 28 Tensile Elongation Yield % ASTM D638 10 ISO 527 Break % ASTM D638 40 ISO 527 Flexural Modulus 73°F (23°C) psi ASTM D790 270,000 MPa ISO 178 1850 Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 3.5 kJ/m2 ISO 180 20.0 Heat Deflection 66 psi °F ASTM D648 190 °C ISO 75 88 264 psi °F ASTM D648 115 °C ISO 75 46 PROPERTY CONDITION UNITS METHOD PRODUCT EXAMPLES 12 www.polyone.com Copyright © 2019, PolyOne Corporation.