Certified Standards For Silicone Foley Catheter
Features of Legensilico Silicone Foley Catheter
- 100% latex-free, uncoated silicone material
- Flexible double-lumen catheter with a sturdy tip for easy insertion
- Features a wide, smooth side port and symmetrical balloon
- The balloon has a smooth surface with no sharp edges
- Equipped with a radiopaque line for easy visualization under X-ray
- 2-way for inflation and drainage
- The drainage port is precisely molded to ensure smooth and effective drainage
Legensilico-100% Medical-Grade Silicone Foley Catheter Manufacturer in China
Legensilico is a direct manufacturer of silicone foley catheter with over two decades of specialized experience in silicone processing. Our Foley catheters are made of transparent, radiopaque (X-ray visible) silicone. These standard double-lumen catheters feature large, smooth side holes to ensure maximum comfort and optimize drainage. Furthermore, they are latex-free, making them safe for patients with latex allergies or sensitivities.
The catheter features small side holes and a symmetrical balloon at the tip; once inflated within the bladder, the balloon secures the catheter in place, effectively ensuring it remains fixed within the bladder. The catheter is single-use and sterile to prevent infection.
We offer standard double-lumen catheters equipped with large, smooth side holes to ensure maximum comfort and optimize drainage. Legensilico also supports customization of catheter sizes, balloon configurations, tips, drainage holes, connectors, colors, packaging, and private label (OEM) requirements.
Please feel free to send an inquiry to receive the latest quote!
Types of Silicone Foley Catheters in Legensilico
2-way silicone Foley catheter typically incorporates a drainage lumen and a separate balloon inflation lumen. It is designed for continuous urinary drainage and indwelling applications.
3-way silicone Foley catheter incorporates an additional lumen for applications such as bladder irrigation. Configuration and intended use should be determined according to the applicable clinical requirements.
Pediatric silicone Foley catheters are designed in smaller sizes for pediatric applications. Legensilico can support customized dimensions and configurations according to customer requirements.
A 100% silicone Foley catheter uses silicone as the primary catheter material and is commonly selected when a latex-free catheter solution is required.
Combining a catheter substrate with silicone coating technology, it provides a smooth outer surface for indwelling catheter applications.
Equipped with an integrated fixed balloon designed to ensure the catheter remains securely in place during indwelling. The balloon volume and configuration are customizable.
Designed with antimicrobial technology to reduce microbial colonization on the surface of the urinary catheter.
A temperature sensor assembly is integrated into the tube, enabling continuous monitoring of bladder temperature while urine is being drained. This product is suitable for clinical scenarios requiring both indwelling drainage and body temperature monitoring.
How We Turn Silicone Into Reliable Products
We support customized silicone products from mold design and material selection to mass production and final quality inspection.
- Manufacturing Process
- Technical Specifications
| Material | 100% Medical Grade Silicone |
| Catheter Design | 2-Way / 3-Way |
| Size | 6 Fr/Ch to 24 Fr/Ch, or custom |
| Length | from 13″ to 26″ |
| Balloon | Integrated Retention Balloon |
| Balloon Capacity | 1.5ml – 30 ml, in 6Fr – 26 Fr sizes |
| Visibility Feature | X-ray detectable line |
| Tip | Standard or Customized |
| Drainage Eyelets | Standard or Customized |
| Connector | Standard or Customized |
| Color | Clear, white, or custom |
| Manufacturing | Silicone Molding, Extrusion & Assembly |
What is a silicone Foley catheter?
A silicone foley catheter is an indwelling catheter made of medical-grade silicone and equipped with a retention balloon, which helps secure the catheter inside the bladder during use. Unlike intermittent catheters, this catheter is designed to continuously drain urine through a drainage tube connected to a collection system.
Applications of Silicone Foley Catheters
Silicone Foley catheters are specifically designed for indwelling catheterization and bladder management in medical settings. Their flexible silicone material and integrated retention balloon make them ideal for clinical applications requiring continuous drainage.
1. Hospital Catheterization and Drainage
Used to provide continuous urine drainage from the bladder to a urine collection bag for hospitalized patients who are unable to urinate normally.
2. Postoperative Care
Silicone Foley catheters can be used for temporary bladder drainage or urine output monitoring following surgery.
3. Urology
Used in urological surgeries and patient management where there are clear clinical indications for indwelling catheterization.
4. Intensive Care
In intensive care settings, Foley catheters may be used when patient management requires precise monitoring of urine output.
5. Urinary Retention Management
Used to drain urine from the bladder when patients are unable to fully empty their bladders due to urinary retention or other clinical conditions.
6. Long-Term Indwelling Catheterization
Silicone Foley catheters may be selected for extended-term indwelling catheterization when assessed by healthcare professionals and found to meet the product instructions for use and clinical suitability requirements.
7. Bladder Irrigation
Three-lumen silicone Foley catheters may be used in situations requiring continuous or intermittent bladder irrigation, such as certain postoperative management procedures in urology.
8. Patient and Elderly Care
Used in hospitals, nursing facilities, and other healthcare settings to serve patients requiring assisted catheterization or bladder management.
9. Urine Output Monitoring
The catheter can be connected to a graduated drainage system to monitor urine output when clinically indicated.
Silicone Foley Catheter Manufacturing
As a silicone processing manufacturer, Legensilico provides one-stop manufacturing support ranging from material preparation to the assembly of finished catheter assemblies.
– Selection of Medical-Grade Silicone Materials
We select silicone materials based on product design and applicable medical device requirements.
– Silicone Extrusion and Molding
We use controlled silicone processing techniques to manufacture catheter bodies and molded components with specific dimensions.
– Catheter Tip and Lateral Port Processing
We mold and process catheter tips and drainage lateral ports in accordance with approved product designs.
– Balloon Molding
We integrate fixed balloons into the catheter structure and inspect them according to established production requirements.
– Component Assembly
Catheter assemblies and connectors are assembled in accordance with approved manufacturing specifications.
– Inspection and Testing
Finished products must pass dimensional, visual, functional, leak, and other quality inspections prior to packaging.
– Packaging
We offer individual packaging, bulk packaging, sterile packaging, and private-label packaging solutions tailored to customer and market needs.
Why Choose Silicone as a Material for Foley Catheter?
Medical-grade silicone is widely used in the manufacture of urinary catheters due to its flexibility, smooth surface properties, and suitability for medical device applications.
– Flexible Silicone Structure
The flexible silicone structure allows the urinary catheter to adapt to its intended application while maintaining its designed shape and drainage function.
– Smooth Surface
A carefully controlled surface finish helps ensure a smooth outer surface, facilitating insertion and drainage.
– Latex-Free Material
Silicone urinary catheters offer a latex-free option for customers developing products that do not contain natural rubber latex.
– Balloon Retention
A built-in retention balloon is designed to help maintain the position of the indwelling catheter. The balloon’s size and volume can be customized according to the product design.
Silicone Foley Catheter vs. Latex Foley Catheter
Both silicone and latex foley catheters are used for indwelling catheterization, but they differ in terms of material properties, patient suitability, and typical application requirements.
| Feature | Silicone Foley Catheter | Latex Foley Catheter |
| Material | Medical-grade silicone | Latex, often natural rubber latex |
| Latex Content | Latex-free | May contain natural rubber latex |
| Biocompatibility | Generally well suited to medical-device applications | Depends on material, formulation, and patient sensitivity |
| Flexibility | Flexible and elastic | Flexible and elastic |
| Surface | Smooth silicone surface | May have a latex surface or protective coating |
| Indwelling Use | Commonly used for indwelling applications | Commonly used for indwelling applications |
| Long-Term Use | Often selected when longer-duration catheterization is clinically appropriate | Duration depends on product design and clinical requirements |
| Balloon | Available with integrated retention balloon | Available with integrated retention balloon |
| Latex Allergy Consideration | Suitable for latex-free product requirements | Requires consideration of latex exposure |
| Chemical Resistance | Generally good resistance to many chemicals | More sensitive to some chemicals and environmental conditions |
| Customization | Sizes, configurations, balloon capacity, connectors, and packaging can be customized | Customization depends on manufacturer and product design |
| Typical Applications | Urinary drainage, urology, postoperative care, intensive care, bladder management | Urinary drainage and general indwelling catheter applications |
In summary, silicone Foley catheters are made of silicone, while latex Foley catheters are made of latex-based materials. For patients with known allergies or sensitivities to latex, latex-free catheters may be considered.
Strict Quality Control Service in Legensilico
Consistent quality is critical in the manufacture of medical catheters. Legensilico implements strict quality control at every stage, including material processing, molding, assembly, inspection, and packaging.
Depending on product specifications, quality control may include:
– Raw material inspection
– Dimensional inspection
– Visual inspection
– Balloon inflation and retention testing
– Leak testing
– Connector inspection
– Drainage performance testing
– Tensile or mechanical property testing
– Packaging inspection
– Batch traceability
– Applicable sterilization-related controls
Testing and acceptance criteria are established in accordance with product specifications and relevant regulatory requirements.
Silicone Foley catheters are primarily used for continuous urinary drainage when indwelling catheterization is clinically required. Applications may include hospital urinary drainage, postoperative bladder management, urology, intensive care, urinary retention management, and other patient-care settings.
A 2-way silicone Foley catheter generally has one lumen for urine drainage and another for inflating the retention balloon. A 3-way Foley catheter has an additional lumen that can be used for bladder irrigation in appropriate clinical applications. The required configuration depends on the intended use and clinical requirements.
The balloon is designed to help retain the catheter in the bladder during indwelling use. It is inflated through a separate inflation lumen using the specified inflation medium and volume.
Yes. Tip configuration and drainage eyelet design can be developed according to the approved product specification. You can provide technical drawings, samples, dimensions, or functional requirements for evaluation before mass production.
Sterile and non-sterile configurations may be available depending on the product design and manufacturing requirements.
Silicone Foley catheters can be manufactured in multiple French (Fr) sizes to accommodate different patient and application requirements. Adult and pediatric configurations may require different dimensions. Legensilico can provide customized sizes and lengths according to approved product specifications.
