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Silicone

Silicone

Silicone

Silicone is an ideal material for a variety of medical device applications.We develop precise, consistently manufactured silicone parts through our custom compounding capability.

Silicone Products Overview

At Saint-Gobain, we develop products with the needs of medical devices in mind, including improved comfort, safety and care for patients.Our silicone products are preferred by medical device manufacturers for superior characteristics and better outcomes. Saint-Gobain’s family of products includes:

Silicone is an excellent material for medical applications due to its reputation for extreme inertness.Silicones have high tear strength, high tensile strength, good elongation, and low compression set.The raw materials can be purchased in a wide durometer range, can withstand a large temperature range, and grades can be used that are USP <88>, Plastic Class VI tested.They are sterilizable with EtO, gamma, ebeam, or autoclaving.

Saint-Gobain offers both extrusion and molding of silicone.Silicone extrusion capabilities include high-speed, tight tolerance tubing for precision fluid delivery medical device applications as well as co-extrusions, and profiles.Depending on the project, we can coil, cut to length, punch, assemble and more.Saint-Gobain processes both platinum and peroxide cured materials.To read more about our extrusion capabilities, click HERE.

With regards to molding, our capabilities include liquid silicone (LSR) molding, overmolding, two-shot molding, micro molding, transfer molding of high consistency rubber (HCR) and compression molding.To read more about our molding capabilities, click HERE.

Bio-Sil® Platinum Cured Silicone

This product is ideal for medical devices requiring strength, durability, long life and non-reactivity with bodily fluids and skin. Available products are:

  • Bio-Sil® 1450 Silicone Tubing
  • Bio-Sil® Precision Pump Tubing

Want to learn more about Silicone? Check out Basics 101: Silicone.
Questions about the wonders of Bio-Sil®? Learn more here.  

 

About Saint-Gobain

Saint-Gobain designs, manufactures and distributes materials and solutions which are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure and in so many industrial applications.

 

Saint-Gobain Performance Plastics' group of businesses gather solutions to save energy, provide protection, improve comfort and sustain the environment for a variety of markets.

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Saint-Gobain’s medical products are distributed exclusively to medical device manufacturers for use in the manufacture, assembly or distribution of their medical devices. Saint-Gobain cannot authorize the sale of its medical products directly to device user facilities (e.g. hospitals, surgery centers, nursing home, clinics, etc.), nor directly to end users (e.g. patients, patients’ caregiver, prescribing physician, nurse, pharmacist, etc.), including distributors serving device user facilities and end users directly. In accordance with every jurisdiction globally, Saint-Gobain’s customers are responsible for determining that any medical device they manufacture and market that incorporates a Saint-Gobain’s medical product, is compliant with each country-specific medical device regulations and has received proper country-specific clearance, certification or registration authorizing the sale of this medical device.


Saint-Gobain’s medical products offer covers:
- Medical Components [21 CFR 820.3(c)], intended for processing or use in the manufacture or assembly of medical devices before the finished medical device is packaged/labeled; Medical Components are intended to be included as part of the finished, packaged, and labeled device [21CFR820.3(c)].
- Finished Devices [21CFR820.3(l)] made on behalf of medical device manufacturers [21 CFR 807.20(a)(2)] under contract-manufacturing agreement. In accordance with the United States’ jurisdiction, Saint-Gobain complies with the FDA’s requirements for contract manufacturers of finished devices.

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