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Medical Grade Silicone: USP Class VI, ISO 10993 & FDA Compliant

Medical grade silicone from ElastaPro is a high-purity elastomer engineered for mission-critical sealing, gasketing, and fluid management in medical devices. Manufactured in the USA, our medical silicones meet the most stringent global standards, including USP Class VI, ISO 10993, and FDA 21 CFR 177.2600.

We supply medical silicone as solid sheets, continuous rolls, and uncured compounds, providing fabricators with the consistent, biocompatible material required for high-reliability healthcare applications.

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Why Choose Platinum-Cured Medical Silicone?

At ElastaPro, our medical silicone sheeting is primarily platinum-cured. Unlike peroxide-curing, platinum-cured systems offer significant advantages for the healthcare industry:

  • Minimized Extractables: Essential for applications involving contact with blood, skin, or biological fluids.

  • No Peroxide By-products: Eliminates the risk of “blooming” or residue that can interfere with sensitive medical diagnostics.

  • Superior Clarity: Translucent grades offer excellent visibility for fluid paths and tubing components.

  • High Tear Strength: Maintains mechanical integrity during repeated sterilization cycles.

[Image comparing platinum-cured vs peroxide-cured silicone structure]

Technical Specifications & Capabilities

We manufacture medical silicone sheeting to precise durometers and dimensions to support custom fabrication and die-cutting.

Property Range / Capability
Durometer (Hardness) 10 to 70 Shore A
Thickness .007” to .500”
Width Up to 60” (Rolls or Sheets)
Operating Temp -80°F to +450°F (Intermittent to 500°F)
Cure System Platinum-Cured (Peroxide available upon request)
Finishes Gloss or Matte

Biocompatibility and Regulatory Standards

ElastaPro materials undergo rigorous testing to ensure safety and performance in diagnostic, wearable, and therapeutic devices.

USP Class VI & ISO 10993 Certification

Our healthcare-grade silicones are tested for acute systemic toxicity, intracutaneous reactivity, and cytotoxicity. These materials are suitable for:

  • Skin Contact & Wearables: Hypoallergenic and non-reactive for long-term skin exposure.

  • Short-Term Implantation: Formulations tested for contact of less than 29 days.

  • Pharmaceutical Processing: Compliant with Ph. Eur Monograph 3.19 for closures and tubing.

Sterilization Compatibility

ElastaPro medical grade silicone retains its elasticity and tensile properties after repeated exposure to common sterilization methods:

  • Autoclave (Steam)

  • Gamma Radiation

  • Ethylene Oxide (EtO)

  • E-beam

Applications for Medical Silicone Sheeting

Our materials are utilized by fabricators to support major medical OEMs in diverse applications:

  • Diagnostic Equipment: Seals for lightweight housings and fluid paths.

  • Wearable Devices: Flexible sensor housings and hypoallergenic patches.

  • Fluid Handling: Precision gaskets for pumps, valves, and pharmaceutical tubing.

  • Lab Instruments: High-purity seals for analytical chemistry equipment.

Contact ElastaPro for more information.