In long-term catheterized patients, bacterial biofilm formation and mineral encrustation (struvite and calcium phosphate) cause painful catheter blockage and bladder spasms. While siliconized latex catheters remain common in short-term post-operative care, hospital infection prevention guidelines for 2026 mandate 100% all-silicone catheters for indwelling periods exceeding 7 days. Here is the clinical specifications and procurement breakdown.
Catheter-associated urinary tract infections (CAUTI) and crystalline encrustation cost healthcare systems billions annually. Here is the clinical engineering comparison of 100% medical-grade silicone versus siliconized latex Foley catheters.
100% all-silicone Foley catheters provide superior lumen drainage area (up to 30% larger than latex of identical French size) due to silicone's structural elasticity. Conforming to ISO 20696 and EN 1616, Manshav Impex manufactures 2-way and 3-way silicone catheters featuring hand-finished drainage eyes, radiopaque tip lines, and symmetrical retention balloons engineered to withstand twice their rated inflation volume without rupture.
Siliconized latex catheters are conventional natural rubber catheters coated with a thin dip-layer of silicone fluid. Over 48 to 72 hours, urine breaks down this surface coating, exposing the underlying latex to mucosal contact and triggering urethral irritation. 100% all-silicone catheters, in contrast, are extruded from high-purity medical-grade polydimethylsiloxane (PDMS), offering complete inertness.
| Clinical Parameter | Siliconized Natural Latex | Manshav 100% All-Silicone (PDMS) |
|---|---|---|
| Approved Indwelling Time | Short-term: Maximum 7 days | Long-term: Up to 30 days continuous indwelling |
| Mucosal Cytotoxicity / Allergy | Latex proteins cause urethritis in 4–8% | Zero cytotoxic response (ISO 10993-5 certified) |
| Biofilm & Encrustation Resistance | Moderate (rougher microscopic surface) | High (hydrophobic non-stick surface) |
| Internal Drainage Lumen Area | Narrower lumen due to thick latex wall | Up to 30% larger lumen for identical Fr size |
| Balloon Deflation Reliability | Latex can form cuffs causing extraction pain | Elastic silicone balloon deflates completely flat |
| Catheter Transparency | Opaque amber / yellow (cannot view urine) | Crystal clear translucent (instant clot detection) |
| Radiopacity for X-Ray / CT | Requires barium strip addition | Co-extruded radiopaque tip and line standard |
An asymmetrical balloon tilts the catheter tip inside the bladder, causing bladder wall erosion, mucosal ulceration, and false sensation of fullness. Manshav Impex applies precision multi-dip molding to guarantee concentric balloon inflation:
| French Size (Fr / Ch) | Outer Diameter (mm) | Balloon Volume | Primary Clinical Indication | Color Code |
|---|---|---|---|---|
| Fr 06 – Fr 10 (Pediatric) | 2.0 – 3.3 mm | 1.5 – 3 ml | Neonatal and pediatric bladder catheterization | Light Green / Blue |
| Fr 12 – Fr 14 (Adult Female) | 4.0 – 4.7 mm | 5 – 10 ml | Routine adult female drainage, post-op care | White / Green |
| Fr 16 – Fr 18 (Adult Male) | 5.3 – 6.0 mm | 5 – 10 ml | Routine adult male drainage, urethral strictures | Orange / Red |
| Fr 20 – Fr 24 (Hematuria 3-Way) | 6.7 – 8.0 mm | 30 ml | Continuous post-TURP bladder irrigation, clot washout | Yellow / Purple |
Each Foley catheter is individually packed in a double sterile blister peel-pouch (inner sleeve + outer peel pouch) conforming to ISO 11607. 10 catheters are packed per inner box, and 500 catheters (50 boxes) per master export carton.
| Container Size | Master Cartons | Total Catheters | Gross Weight (kg) | CBM Volume |
|---|---|---|---|---|
| 20ft Ocean Container | 300 Cartons | 150,000 Pcs | 4,200 kg | 28.0 CBM |
| 40ft High Cube Container | 650 Cartons | 325,000 Pcs | 9,100 kg | 62.5 CBM |
| Consolidated Urology Order | Catheters + Urine Bags | Custom Mix | As scheduled | Shared CBM |
Pre-donned sterile natural latex surgical gloves with curved anatomical fingers, micro-textured anti-slip finish, beaded cuff, available in powdered and powder-free polymer coated grades. Container consignments dispatched from Port Mundra & Port Nhava Sheva, with certificates and test reports shared with every quotation.
100% silicone is biologically inert and contains zero natural latex proteins, eliminating allergic urethritis and tissue irritation. Its hydrophobic surface resists mineral encrustation and biofilm attachment, allowing safe continuous indwelling for up to 30 days compared to only 7 days for latex.
Silicone possesses higher tensile rigidity than natural latex, allowing manufacturers to engineer thinner catheter walls without risk of lumen collapse. This results in an internal drainage lumen up to 30% wider than an equivalent latex catheter.
Always inflate the balloon with sterile water. Saline solution should never be used because salt crystals can precipitate inside the inflation valve channel, preventing proper balloon deflation when the catheter needs to be removed.
A 2-way catheter has two channels: one for urine drainage and one for balloon inflation. A 3-way catheter has a third channel dedicated to continuous bladder irrigation fluid infusion, commonly used in urology post-prostatectomy or for severe hematuria.
Yes. We supply 2,000 ml sterile urine collection bags with anti-reflux valves, needleless sampling ports, and bottom T-tap drainage outlets to form complete closed urological drainage systems.
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