| 1. Please contact PolyOne GLS Thermoplastic Elastomers for a copy of the FDA compliance letter. |
| 2. Please contact PolyOne GLS Thermoplastic Elastomers for a complete copy of the GLS Healthcare Policy. 1. The Customer must notify GLS of any FDA Class I and/or European Union Class I medical devices for each specific product and application. 2. The Customer shall not knowingly manufacture, use, sell or otherwise supply, directly or indirectly products or compounds made from GLS products in any of the following without prior written approval by GLS for each specific product or application: a. Cosmetics b. Drugs and other Pharmaceuticals c. Temporary or permanent implantation in the human body, regardless of the intended duration of implantation d. Class II and Class III Medical Devices as defined in 21 CFR 860.3 (“Medical Devices”) e. Class IIa, IIb and III as defined in Directive 93/42/EEC |
| 3. Typical properties: these are not to be construed as specifications. |
| 4. Die C |
| 5. 2 hr |
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