Product Information for Europe CYROLITE® Protect acrylic-based microbe resistant compounds These products are specifically designed for FDA regulated Class I or Class II medical devices covered by 510(k) PMN submission. CYROLITE® Protect and CYROLITE® Protect 2 acrylic-based microbe resistant compounds - provides resistance to polymeric decomposition that could be caused by microbial infestation. Call Evonik Cyro for the Device Master File Numbers. Polymer Grades Color Characteristics CYROLITE® Protect acrylic-based multipolymer compound G23P 02041 Green Transparent green tint, easy to process and free of bisphenol A (BPA) CYROLITE® Protect 2 acrylic-based multipolymer compound F22P 00398 Blue Transparent blue tint, free of bisphenol A (BPA), superior resistance to lipids and alcohol as well as excellent ductility Regulatory and Compliance Requirements Benefits REACH: CYROLITE® all grades comply with REACH regulations and Substances of very high concern (most recent SVHC listing from date of publication) are not present in concentrations of 0.1% or higher. CYROLITE® Protect and CYROLITE® Protect 2 are treated articles under REACH. • Chemical Resistance to lipids and alcohol CYROLITE® Grades Protect and CYROLITE® Protect 2 comply with RoHS without using substances named in the European Directive 2011/65/EC (replace 2002/95/EC, the amendment 2008/35 EC Inclusive Decision of Commision 2009/443/EC) , do not contain heavy metals , nor phthalates nor natural latex nor conflict minerals. Both Grades meet the requirements of the Unites States Pharmacopeia Class VI; and FDA Food Contact for all conditions up to and including hot filled or pasteurized above 65 °C (150 °F) (e.g. condition 21 CFR 176.170 ) for all food types except those containing more than 8% alcohol. Specific grade and color G203P 02041 Green and F22P 00398 Blue. • Resistance to microbes is inherent in the polymer • Easily welded • Bondable to PVC tubing • Excellent impact strength • EtO, gamma and e-beam sterilizable Processing All protect grades can be processed in injection molding machines and extrusion lines with 3-zone general purpose screws. Packaging Available in 680.5 KG (1500 lb.) Gaylord Boxes: other packaging available on request. Evonik Cyro LLC | CYROLITE® Protect, CYROLITE® Protect 2 | 3870-0714-cyro Page 1/2 CYROLITE® Protect polymer grades Properties Unit ASTM CYROLITE® Protect 2 F22P CYROLITE® Protect G23P Mechanical Properties Typical Value Typical Value Tensile Strength MPa (psi) D 638 40.3 (5,840) 47.2 (6,850) Tensile Modulus GPa (x106 psi) D 638 1.8 (0.26) 2.1 (0.33) Tensile Elongation @ Yield % D 638 4 3 Tensile Elongation @ Break % D 638 17 8 Flexural Strength MPa (psi) D 790 61 (8,840) 70.2 (10,200) Flexural Modulus Gpa (x106 psi) D 790 1.9 (0.28) 2.2 (0.325) Notched Izod on ¼'' bar @23°C J/m (ft-lb/in) D 256 91 (1.7) 64 (1.3) Thermal Properties Vicat Softening Point °C (°F) D 1525 94 (201) 100 (212) Deflection Temperature, Annealed 1.8MPa, 0.250'' °C (°F) D 648 65 (149) 75 (167) Rheological Properties Melt Flow Rate @ 230°C g/10min D 1238 2.5 @5.0 kg 10.0 @5.0 kg Optical Properties Light Transmission % D 1003 11 @1.5mm 40 @3mm Haze % D 1003 32 @1.5 mm 48 @3mm Processing Conditions Predrying Temperature °C (°F) 71 (160) 79 (175) Predrying Time hour 3 to 4 3 to 4 Melt Temperature °C (°F) 238 - 254 (460 - 490) 232 - 249 (450 - 480) Mold Temperature °C (°F) 60 - 77 (120 - 170) 50 - 82 (120 - 180) Evonik Cyro LLC | CYROLITE® Protect, CYROLITE® Protect 2| 3870-0714-cyro Page 2/2 This information and all technical and other advice are based on Evonik’s present knowledge and experience. However, Evonik assumes no liability for such information or advice, including the extent to which such information or advice may relate to third party intellectual property rights. Evonik reserves the right to make any changes to information or advice at any time, without prior or subsequent notice. EVONIK DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, AND SHALL HAVE NO LIABILITY FOR, MERCHANTABILITY OF THE PRODUCT OR ITS FITNESS FOR A PARTICULAR PURPOSE (EVEN IF EVONIK IS AWARE OF SUCH PURPOSE), OR OTHERWISE. EVONIK SHALL NOT BE RESPONSIBLE FOR CONSEQUENTIAL, INDIRECT OR INCIDENTAL DAMAGES (INCLUDING LOSS OF PROFITS) OF ANY KIND. It is the customer’s sole responsibility to arrange for inspection and testing of all products by qualified experts. Reference to trade names used by other companies is neither a recommendation nor an endorsement of the corresponding product, and does not imply that similar products could not be used. CYROLITE® is a registered trademarks of Evonik Cyro LLC, an Evonik Corporation group company. ©2013 Evonik Cyro LLC. All rights reserved. Printed in USA. Evonik Cyro LLC – Acrylic Polymers 299 Jefferson Road, Parsippany, NJ 07054 USA www.cyrolite.eu e-mail: cyrolite-europe@evonik.com