Overview:
Our OEM One-Way Cross Slit Silicone Valve Sealing for Medical Usage is a high-performance, precision-engineered component designed to control fluid and air flow in medical devices. Crafted from medical-grade silicone, this valve utilizes advanced compression molding technology to ensure exceptional reliability, flexibility, and durability. The cross-slit design offers superior sealing capabilities, allowing for controlled fluid dispensing and leakage prevention in medical applications. Manufactured in compliance with ISO 13485 and FDA standards, our one-way silicone valve sealing provides optimal performance for medical applications requiring reliable, biocompatible components. We offer full OEM services including custom sizing, color options, and branding integration to meet your specific requirements.
Basic Information:
| Attribute | Details |
|---|---|
| Material | Medical-Grade Silicone |
| Place of Origin | Xiamen, China |
| Brand Name | OEM |
| Size | Custom |
| Color | Transparent, Custom Colors |
| Packing | OPP bag, PVC box, or customized packaging |
| Temperature Range | -40 to +230 °C |
| OEM | Available |
| MOQ | Small orders can be accepted |
| Sample | Available |
| Technology | Silicone Compression Molding |
| Certification | ISO 13485, FDA, RoHS, CE |
Benefits of Our Products:
- Biocompatible and Safe: Made from medical-grade silicone, ensuring safe contact with fluids and materials used in medical applications.
- Superior Sealing Performance: The cross-slit design allows for a one-way seal, preventing leaks and ensuring precise fluid control.
- Heat and Chemical Resistance: With the ability to withstand temperatures ranging from -40°C to +230°C, the silicone valve performs reliably even under extreme conditions.
- Customization Flexibility: Fully customizable in terms of size, color, hardness, and actuation force, ensuring a perfect fit for your medical device needs.
Quality Assurance:
Our quality assurance process for OEM One-Way Cross Slit Silicone Valve Sealing for Medical Usage follows stringent industry standards. We are ISO 13485 certified, ensuring compliance with medical device manufacturing standards. The silicone material is pre-tested for purity, biocompatibility, and BPA/phthalate-free verification. During production, we employ advanced in-line testing and inspection, including tensile testers for material strength, durometers for hardness verification, and 3D CMM systems for dimensional accuracy.
After molding, each valve undergoes rigorous leak-proof testing, thermal cycling tests, and high-pressure performance assessments. Our dedicated QA team ensures every product meets the highest standards for safety, durability, and reliability. We also offer batch traceability and full compliance with FDA and RoHS standards to guarantee the highest quality at all stages of production.
Why Choose Us for Your Silicone Valve Manufacturing?
- Expertise in Medical Silicone Manufacturing: With over 20 years of experience in producing medical-grade silicone components, we deliver high-quality products with proven reliability and safety.
- Custom Solutions for Every Need: Our OEM services offer complete customization options, including size, color, and design, to meet your specific medical application requirements.
- End-to-End Support: From initial design and prototyping to full-scale manufacturing and delivery, we provide seamless project management, ensuring timely execution and exceptional service.
- Rigorous Quality Control: Our ISO 13485-certified quality management system ensures strict compliance with international standards, providing consistently high-quality products that meet the demands of the medical industry.
Our Factory:
Our advanced manufacturing facility is equipped with state-of-the-art technologies, including CNC machining, mirror EDM, conventional EDM, and high-precision wire cutting systems, ensuring unparalleled mold accuracy and repeatability. The 15 rubber compression presses and 2 LSR injection molding machines on our production line are configured to optimize throughput and produce tight-tolerance silicone components, including one-way valve seals.
Quality control is ensured through the use of advanced inspection tools such as 3D projectors, sealing testers, durometers, and elasticity gauges, all overseen by our certified QA specialists. Our processes are fully accredited by ISO 9001, IATF 16949, and ISO 13485, ensuring the highest standards of reliability, biocompatibility, and product integrity.Contact us today to create your custom silicone valve sealing solutions for medical devices, and ensure top-quality performance and compliance with industry standards.
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