ELASTOSIL LR 34004/50 A/B is a paste-like, white two-component liquid silicone rubber with a very short curing time. Vulcaniates are noted for their radio-opaqueness.ELASTOSIL LR 34004/50 A/B contains barium sulfate as a radio-opaque additive which meets the requirements of the US and European Pharmacopoeia.
Specific features
• Food-contact
• Reduced volatile content
• X-ray opaque
Applications
• Medical Equipment
Application details
ELASTOSIL LR 34004/50 A/B is particularly suitable for the economical production of large series of injection-moulded articles. ELASTOSIL LR 34004/50 A/B is designed for medical and pharmaceutical applications. Properly cured and post-cured vulcanizates of ELASTOSIL LR 34004/50 A/B can be used for food contact applications and are suitable for use under the Recommendation "XV. Silicones" of the BfR and FDA 21 CFR §177.2600 "Rubber Articles Intended for Repeated Use" considering any given limitations on extractable and volatile substances.
The following studies were performed on vulcanizates of ELASTOSIL LR 34004/50 A/B according to ISO 10993:
- Cytotoxicity (ISO 10993-5)
- Sensitation LLNA (ISO 10993-10)
- Pyrogenicity (ISO 10993-11)
The following studies were performed on vulcanizates of ELASTOSIL LR 34004/50 A/B according to USP class VI:
- Acute systemic toxicity
- Intracutaneous toxicity
- Implantation test
No adverse effects have been detected at any of the studies performed.
First level agent
Glory Hill International Enterprise Limited
Telephone:+852 6037 6803
E-mail:hillman@glory-hill.com