Saint-Gobain Seals Group Provides Sustainable Solution for Handheld Surgical Tool with FDA Compliant Rulon® Polymer Material
GARDEN GROVE, CALIFORNIA — Saint-Gobain Seals Group continues to provide sustainable solutions for handheld surgical power tools in the medical and dental fields as a key supplier of Rulon® components in harmonic scalpel surgical tooling. Harmonic scalpels use ultrasonic technology to simultaneously cut and coagulate tissue and are utilized as an alternative to metal scalpels and electro-surgical devices. Benefits of the harmonic scalpel include greater precision, fewer instrument changes, the ability to cut through thicker tissue with more efficiency and an improved field of view due to the reduced amount of smoke created by the system.
The Seals Group's Rulon® product is a fluoropolymer based material with low frictional properties and superior resistance to high service temperatures, which are notable advantages during use of the harmonic scalpel. Rulon® materials appropriate for this application can withstand temperatures up to 550°F (288°C), making them ideally suited for steam autoclaving. Depending on the application conditions, eight Rulon® materials are available that are either FDA compliant (Title 21 CFR §177.1550), USP Class VI certified, and/or EU 1935/2004 and 10/2011 compliant.
Aside from contributing to the precision and efficiency of the harmonic scalpel, the Seals Group has also provided other sustainable polymer solutions in the Life Sciences industry through its Meldin® 7000 and Meldin® HT product lines that are suitable for gamma and e-beam sterilization. Another example of a surgical tool application is the use of their OmniSeal® spring-energized seals and Meldin® injection molded PEEK bearings in a groundbreaking powered stapling system, the only full-powered, reusable, battery operated endoscopic stapler in the world. As a trusted manufacturing partner in the Life Sciences market for over 30 years, their sealing and polymer designs address critical sealing, friction control, chemical compatibility, material compliance and weight reduction.Â
In addition to the above product lines, the Seals Group's product offering includes Fluoroloy® material, consisting of a family of proprietary materials that are composed primarily of polytetrafluoroethylene (PTFE) based resins (similar to Rulon®), and developed to perform in the most diverse and extreme applications for various markets such as Life Sciences, Aerospace, Oil & Gas and Automotive. There are more than 100 standard Fluoroloy® and Rulon® grades available, several of which are FDA compliant and USP Class VI certified, making them well suited for medical and analytical equipment applications.
About Saint-Gobain Seals Group (www.seals.saint-gobain.com)
Saint-Gobain Seals Group is a business unit under Saint-Gobain Performance Plastics' Engineered Components division; our parent company is one of the world's top 100 industrial groups. With more than 50 years of manufacturing experience and an established global presence (with strategic sites in Garden Grove, California, USA; Kontich, Belgium; and Minhang, Shanghai, China), we offer a diverse range of innovative sealing and polymer solutions:Â
Spring-Energized Seals
PTFE Rotary Shaft Seals
Fluoroelastomer Seals
EMI / RFI Shielding Solutions
High-Performance Fluoropolymer Compounds
Thermoset Polyimide Materials
High-Performance Thermoplastic Materials
Other products include Fluoroloy® (high-performance custom-formulated compounds and alloys), cup seals, hydraulic seals, metal seals, v-packings, piston rings, Marathon® (valves and vacuum pump diaphragms), Transband® (PTFE creepage band), custom parts, polymer bearings and stock shapes.
The majority of seals and polymer components manufactured are custom designed and matched with the best materials to optimize their performance in various applications and markets.
