Seal King - Your FDA Approved Sealing Solution Specialist
Compliant Materials and Complete Traceability Chain
Medical-grade materials that meet FDA, USP Class VI, and ISO 10993 certifications are available with detailed traceability documentation and biocompatibility reports, allowing you to meet the rigors of 21 CFR Part 820.
High Precision Manufacturing and Batch Consistency
The use of clean room precision CNC machining to lock the dimensional tolerances within a very small range ensures that the hardness and surface quality of each batch of seals are perfectly consistent, eliminating technical defects during the audit process.
Professional validation support and schedule control
With in-depth experience in FDA certification collaboration, we provide the technical documentation required for change validation to help you remove regulatory hurdles in advance and dramatically shorten the revalidation timeframe.
Chengxin Sealing King’s medical-grade sealing solutions are widely used in various types of precision medical devices, ensuring their stable operation under stringent regulatory requirements and safeguarding patient safety.
O-ring for IV infusion system
Used in fluid delivery devices such as infusion pumps and dialysis machines, the key to ensuring leak-free delivery of medicinal solutions lies in biocompatibility and corrosion resistance.
Gaskets for Diagnostic Equipment
Widely used in blood analyzers and diagnostic imaging equipment, it provides a secure seal to prevent cross-contamination and ensure accurate test results.
Diaphragms for Medication Delivery Pumps
For example, the precision diaphragms used in insulin pumps and nebulizers must possess high elasticity, long-term stability, and chemical inertness toward drugs.
Custom Seals for Surgical Instruments
Custom-made to meet the specific requirements of surgical instruments, these products withstand high-temperature sterilization and repeated use, ensuring sterile procedures and safety.
Diagnostic and Testing Equipment
For example, blood analyzers, ultrasound machines, and endoscopes—ensure that the internal fluid or gas pathways are sealed and leak-free to guarantee the accuracy of test results.
Therapeutic and Interventional Devices
These include surgical instruments, cardiac catheters, ventilators, and other devices; the seals in these devices must withstand high-temperature sterilization and exhibit excellent biocompatibility.
Implantable Medical Devices
For example, in applications such as artificial heart valves and seals around orthopedic implants, the materials must exhibit extremely high purity, long-term stability, and biocompatibility with human tissue.
Drug Delivery System
From infusion pumps and insulin pens to nebulizers, seals must ensure precise control of drug dosages and prevent chemical reactions between the medication and the sealing materials.
- R&D Manager for a leading diagnostic equipment manufacturer.
- Quality Director, Surgical Instrument Company
- Drug Delivery System Developer Technical Supervisor
Needs Analysis and Consultation
Understand your product characteristics, usage environment and certification requirements, and provide preliminary material and design recommendations. Our technical team will evaluate your specifications and propose the most suitable sealing solution.
Design Development and Simulation
CAD/CAE tools are used for structural design and performance simulation to optimize sealing effectiveness and manufacturing feasibility. We consider FDA approval requirements to ensure compliance at the design stage.
Sample making and testing
Rapidly produce samples and conduct performance tests, including dimensional inspection, sealing tests, material compatibility evaluation, etc. Make necessary design adjustments based on test results.
Document preparation and certification support
Provide complete technical files, including material certificates, test reports, and process documentation. Assist you in preparing the sealing components for FDA application and answer technical questions during the review process.
Mass Production and Quality Assurance
After passing the certification, we provide stable mass production supply and continuous quality control. Each batch of products is accompanied by an inspection report and a declaration of conformity to ensure the consistency of long-term supply.
Choose Cheng Hsin Seal King to make your path to FDA certification smoother. We not only provide high quality sealing components, but also your reliable technical partner. No matter where you are in the product development stage, we can provide professional support and service.
Contact us now to take advantage of the following offers: