Medical Grade HTV Silicone Rubber

Our medical grade silicone rubber – HTVWIC’s – are high-purity, odorless, and transparent compounds specifically developed for medical and healthcare applications, featuring excellent Sterilizability. Available in two distinct types, HTVWIC-P and HTVWIC-F, with hardness ranging from 30 to 70 Shore A, they come with both transparent and pigmented options.

These materials are fully customizable through our in-house compounding services, allowing precise adjustment of mechanical and processing properties to meet specific customer requirements.

Key Highlights

Medical-Grade Biocompatibility

High-purity HTV silicone compliant with FDA and ISO 10993, suitable for direct medical and food-contact applications.

Non-Toxic & Additive-Free

Free from plasticizers and harmful additives, ensuring long-term safety in medical and pharmaceutical environments.

Wide Temperature Stability

Maintains flexibility and mechanical strength across a broad range from –50°C to +200°C.

Sterilization Resistant

Fully compatible with autoclave, gamma irradiation, and ethylene oxide (EO) sterilization processes.

Flexible Hardness Range

Available in Shore A 20–70, offering excellent elasticity, tear resistance, and compression recovery.

Versatile Processing

Designed for extrusion, compression molding, and precision-formed medical components.

Custom Colors & Formulation

Custom hardness and color options available for product identification and application-specific needs.

Long-Term Performance

Reliable mechanical and chemical stability for long-term medical and pharmaceutical use.

Technical Data

Medical Grade HTV Silicone

Code	Hardness	Tensile (MPa)	Elongation (%)	Tear strength (N/mm)
HTVWIC-70 A/B	70
HTVWIC- 65 A/B	65	8.25	853	45.5
HTVWIC- 53 A/B	53	6.6	852	41.3
HTVWIC- 45 A/B	45	7	825	32.2
HTVWIC- 40 A/B	40	7	841	22.2
HTVWIC- 35 A/B	35	5.5	834	25
HTVWIC- 30 A/B	30	2.4	547	9.4

Note: * Formulations can be customized to meet your precise technical specifications, including desired physical and chemical properties.

Typical Applications

Medical Tubing & Catheters

Safe, flexible, and fully body-contact approved for tubes, catheters, and fluid transfer systems.

Device Seals & Gaskets

Leak-proof and durable under medical sterilization conditions, ideal for pumps, valves, and diagnostic devices.

Surgical Handles & Grips

Heat-sterilizable, ergonomic, and comfortable for repeated clinical use.

Implantables & PPE

Chemically inert and durable under sterilization; suitable for PPE components, implants, and wearable devices.

Pharma Packaging & Lab Parts

Non-reactive in pumps, valves, containers, and laboratory equipment, maintaining purity and chemical stability.

Medical Device Grommets & Bushings

Flexible sealing solutions for tubing entries, connectors, and device housings.

Patient Contact Surfaces

Smooth, soft, and biocompatible surfaces for medical devices in direct patient contact.

Diagnostic & Laboratory Components

Precise, chemical-resistant parts for analyzers, test kits, and lab automation equipment.

Compliance & Quality

ISO 9001 – Quality Management
Meets FDA standards –ensuring safety and reliability.
ISO 10993-4: Tests for blood-material interactions.
ISO 10993-10: Evaluation for skin irritation and sensitization.
ISO 10993-5: In vitro cytotoxicity testing for medical devices.
Batch-tested for strength & durability
Fully traceable batch documentation
ASTM / ISO standards verified
RoHS / REACH compliant

Performed Tests

Tensile Strength (ASTM D412)

Elongation at Break (ASTM D412)

Tear Strength (ASTM D624)

Hardness – Shore A (ASTM D2240)

Compression Set (ASTM D395)

Heat Aging / Thermal Stability (ASTM D573)

Thermal Shock / Thermal Cycling

Low-Temperature Flexibility (ASTM D2137)

Rheometric / Cure Analysis (MDR / ODR)

Cure Uniformity & Crosslink Density

Rheology / Flow Behavior

Oil & Fluid Resistance (ASTM D471)

Chemical Resistance (ASTM D543)

Weathering & UV Resistance (ASTM G154)

Dielectric Strength (ASTM D149)

Volume Resistivity (ASTM D257)

Electrical Insulation Performance

Specific Gravity / Density (ASTM D792)

Biocompatibility (ISO 10993)

Sterilization Resistance (Steam / EtO / Gamma)

Request Sample

We’re excited to provide you with a sample of our high-quality silicone products. Please fill out the form below with your technical specifications and requirements. Include any datasheets or drawings using the file upload option, so our team can prepare the exact sample you need. Our team will review your request promptly and get back to you with details, availability, and delivery information.