https://www.avient.com/sites/default/files/2025-02/case study snapshot-Ostomy bag-G2705.pdf
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?
AVIENT SOLUTION
COMPLIANCE + TECHNICAL SUPPORT
LEARN MORE
Copyright © 2025, Avient Corporation.
https://www.avient.com/news/polyone-delivers-certified-ok-compost-home-colorants-simplify-bio-degradable-packaging-compliance
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PolyOne Delivers Certified OK Compost HOME Colorants to Simplify Bio-Degradable Packaging Compliance
https://www.avient.com/news/polyone-wilflex-screen-printing-inks-receive-key-2014-regulatory-certifications
PolyOne Wilflex maintains comprehensive procedures for raw material review to support compliance programs.
Wilflex inks have passed third party testing for 2014 product compliance and regulatory standards, including:
For more information on product specific test results, please click here to view to the 2014 PolyOne Wilflex General EH&S Conformity Statement Wilflex Compliance or visit www.wilflex.com/compliance.
https://www.avient.com/sites/default/files/2021-10/versaflex-top-cover-of-air-cushion-powder-case-study-one-pager.pdf
Cosmetic brands
COSMETIC BRANDS
C O V E R O F A I R C U S H I O N
P O W D E R C O M P A C T
• Low coefficient of friction (COF) to balance the opening
pressure and sealing performance
• General FDA compliance
• Good chemical resistance and barrier protection to water
and oxygen
• Overmold to PP with good compression set
• Delivered chemically resistant material with
excellent sealing properties and good
resilience to achieve requested
performance
• Provided onsite technical support to
improved injection speed and achieve good
bonding performance
• Offered a material solution that could be
leveraged across the customer’s global
cosmetic brands
Custom Versaflex™ TPE
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/thermoplastic-elastomers/versalloy-thermoplastic-elastomers
Custom Versalloy™ HC 9220-90 formulation provides regulatory compliance for drug transfer device
Versalloy™ XL TPV alloy grade delivers an FDA-compliant and color-matched solution for an automotive OEM
https://www.avient.com/resource-center?document_type=59&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form&page=8
Stat-Tech™ TPE meets ATEX standard and FDA food contact compliance in food processing conveyor belt
https://www.avient.com/products/polymer-additives/processing-enhancement-additives/cesa-stat-antistatic-additives
FDA-approved and bio-based formulations available
Our portfolio can help reduce the risk of fire hazards, ensure regulatory compliance, or maintain product appearance.
https://www.avient.com/company/sustainability/sustainability-report/products/no-surprises-pledge
You can expect that the materials we produce contain only ingredients that conform to accepted legal and regulatory compliance guidelines.
When you choose Avient, you can be confident our products will help you meet or exceed today’s stringent compliance standards
https://www.avient.com/sites/default/files/2023-07/Avient_RY 2022 CDP Verification Opinion Declaration_07-24-23%5B30%5D.pdf
This verification opinion declaration
applies to the related information included within the scope of work described below.
Miami, Florida Lakewood, Colorado
July 24, 2023
This verification declaration including the opinion expressed herein, is provided to Avient and is solely for the benefit of Avient in
accordance with the terms of our agreement.
We consent to the release of this declaration by you to the public or other
organizations but without accepting or assuming any responsibility or liability on our part to any other party who may have access to
this declaration.
https://www.avient.com/sites/default/files/2021-04/versalloy-medical-tubing-case-study.pdf
The hose manufacturer decided to explore other
material options that would meet requirements such
as excellent colorability, good surface appearance,
high flow for optimal productivity, and of course,
compliance with U.S.
Food and Drug Administration
(FDA) regulations.
The Avient team
assessed the application’s technical and operational
requirements, and recommended GLS Versalloy™ XL-
9045-1 alloy in 45 Shore A durometer, an FDA-compliant
medical TPV grade designed for overmolding onto PP.