Medical Grade Liquid Silicone Sterile Catheter Connector

# Medical Grade Liquid Silicone Sterile Catheter Connector

The 19 Fr medical liquid silicone catheter connector is a precision-molded sterile interface component designed to create leak-proof, biocompatible connections between catheter tubing, fluid delivery systems, and patient access devices. Manufactured via injection molding of medical-grade liquid silicone rubber (LSR), this connector meets the strict performance and safety requirements of invasive and non-invasive medical procedures, eliminating the risk of disconnection, fluid leakage, and cross-contamination common with traditional polyvinyl chloride (PVC) or polypropylene (PP) alternatives.

Product Overview

This 19 Fr catheter connector is engineered for universal compatibility with standard 19 French (6.35 mm inner diameter) catheter tubing, luer lock ports, syringe adapters, and fluid collection bags. Its core design features a barbed insertion end for secure tubing attachment, a standardized luer lock or slip fitting interface for device connection, and a seamless, flash-free surface that minimizes bacterial adhesion. As a single-use sterile component, it eliminates the need for reprocessing, reducing clinical workload and cross-contamination risks.

Key selling points include:

• Class VI biocompatibility suitable for short-term (≤30 days) and long-term (≥30 days) implantation and mucosal contact applications
• Wide working temperature range compatible with autoclaving, ethylene oxide (EtO) sterilization, and gamma irradiation
• Low compression set that maintains a consistent sealing force even after extended use under flexural or tensile stress
• Translucent material formulation that allows visual confirmation of fluid flow and air bubble removal during setup
• Compatibility with all common medical fluids, including blood, saline, chemotherapeutic agents, and parenteral nutrition solutions

Technical Specifications

Material Properties

All connectors are manufactured from medical-grade platinum-cured liquid silicone rubber that meets USP Class VI, ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and skin sensitization), and ISO 10993-11 (systemic toxicity) standards. The material contains no latex, phthalates, PVC, or harmful additives, making it suitable for use on patients with latex allergies or sensitive skin.

Physical Performance

The 19 Fr connector is precision molded to tight dimensional tolerances to ensure consistent fit across all compatible devices. Its mechanical properties are optimized to balance flexibility for easy insertion and rigidity for secure locking:

Process Parameters

All connectors are produced in an ISO Class 7 cleanroom environment using automated LSR injection molding to eliminate human contact and reduce contamination risk:

Product Advantages

1. Superior Biocompatibility and Safety

Unlike plastic connectors that may leach phthalates or other additives during use, our LSR connector is inert and non-reactive with all common medical fluids and medications. It does not cause tissue irritation or sensitization, even during prolonged mucosal or tissue contact, making it suitable for sensitive applications such as neonatal care, oncology treatment, and long-term urinary catheterization. The latex-free formulation eliminates the risk of anaphylactic reactions in latex-allergic patients.

2. Reliable Leak-Proof Performance

The barbed insertion end features three precision-molded circumferential ribs that create a multi-point seal when inserted into catheter tubing, preventing accidental disconnection even under high fluid pressure or patient movement. The low compression set of LSR ensures the seal remains intact for the entire duration of use, eliminating the risk of fluid leakage that can lead to wound contamination, medication dosing errors, or healthcare worker exposure to biohazardous fluids. The connector has passed 10,000 flex cycles without leakage in simulated clinical use testing.

3. User-Friendly Ergonomic Design

The connector’s slightly flexible body allows for one-handed installation, reducing setup time for clinical staff during emergency procedures. The translucent material allows for unobstructed visual inspection of fluid flow, enabling quick identification of air bubbles, blockages, or catheter malfunctions. The luer lock interface is compatible with all standard medical luer devices, eliminating the need for custom adapters and reducing inventory complexity for healthcare facilities.

4. Cost-Effective and Regulatory Compliant

Each batch of connectors is fully traceable and comes with a complete set of regulatory documentation, including FDA 510(k) clearance, CE marking under the MDR 2017/745 regulation, and ISO 13485 quality system certification. As a single-use pre-sterilized component, it eliminates the labor and cost associated with reprocessing reusable connectors, while also reducing the risk of hospital-acquired infections (HAIs) linked to improperly sterilized equipment.

Applications

This 19 Fr medical LSR catheter connector is used across a wide range of clinical specialties, including but not limited to:

• Urinary Care: Connection between Foley catheters and urine collection bags for short-term and long-term urinary drainage, including for patients with urinary retention or post-surgical recovery needs
• Gastroenterology: Attachment to nasogastric (NG) tubes, gastrostomy tubes, and jejunostomy tubes for enteral nutrition delivery, gastric decompression, and gastrointestinal fluid drainage
• Respiratory Care: Interface between tracheostomy tubes, suction catheters, and mucus collection systems for airway management in intensive care units (ICUs) and home care settings
• Surgical Procedures: Use in minimally invasive surgeries for fluid irrigation and suction, including laparoscopic, arthroscopic, and obstetric/gynecologic procedures
• Infusion Therapy: Connection between large-bore peripheral catheters and rapid infusion systems for trauma care, blood transfusion, and high-volume fluid delivery
• Wound Care: Interface between negative pressure wound therapy (NPWT) devices and wound drainage catheters for management of chronic wounds, surgical incisions, and trauma injuries

Selection Guide

Hardness Selection

• 40 Shore A: Recommended for applications requiring maximum flexibility, such as neonatal catheters or use on sensitive mucosal tissue, where reduced insertion force is a priority.
• 50 Shore A (Standard): Balances flexibility and rigidity, suitable for most general clinical applications including urinary drainage, enteral feeding, and routine suction procedures.
• 60 Shore A: Recommended for high-pressure applications such as rapid fluid infusion, surgical irrigation, and negative pressure wound therapy, where higher structural rigidity is required to prevent connector deformation under load.

Size Specifications

This product is offered as a 19 Fr (6.35 mm outer diameter) connector as standard, but we also provide custom sizes ranging from 6 Fr (2 mm) to 30 Fr (10 mm) to match non-standard catheter tubing dimensions. Custom end configurations, including male luer slip, female luer lock, and threaded adapter interfaces, are available on request for specialized device integration.

Material Grade

• Standard Medical Grade: Suitable for all non-implantable applications including external drainage, enteral feeding, and short-term mucosal contact (≤29 days).
• Implantable Grade: For applications requiring long-term tissue contact (≥30 days) or temporary implantation during surgical procedures, meeting additional ISO 10993-6 (local effects after implantation) testing requirements.
• Radiopaque Grade: Formulated with 20% barium sulfate to enable X-ray visibility for use in interventional radiology and surgical procedures where connector positioning needs to be confirmed via imaging.

Quality Assurance

We operate an ISO 13485:2016 certified quality management system for all medical device production, with end-to-end traceability from raw material batch to finished product. Each connector undergoes 100% in-line inspection for dimensional accuracy, surface defects, and fit integrity, followed by batch testing for burst pressure, biocompatibility, and sterility validation.

All products are sterilized in compliance with ISO 11137 standards, with each batch accompanied by a sterility certificate and gamma irradiation dose report. We conduct quarterly third-party testing to verify compliance with USP Class VI and ISO 10993 biocompatibility requirements, and maintain full documentation for regulatory submissions to support your device approval processes. We offer a 2-year warranty against manufacturing defects, and our technical team is available to provide custom design support, material testing, and regulatory guidance for your specific application requirements.