Foley Catheter 2-Way Latex Silicone Coated 14Fr

Description

1. Product Overview

The Foley Catheter 2-Way Latex Silicone Coated 14Fr is a sterile, single-use medical device designed for continuous bladder drainage in acute care, surgical, and long-term catheterization settings. Its primary industrial application lies within hospitals, outpatient surgical centers, and home healthcare distribution channels requiring reliable urinary management solutions. The key value proposition is the optimal balance of biocompatibility and mechanical strength: a natural latex base provides flexibility and kink resistance, while a uniform silicone coating reduces urethral friction and encrustation risk. Strategically, this product addresses the global demand for cost-effective yet clinically safe catheters, especially in markets transitioning from uncoated latex to higher-performance alternatives without the premium cost of full silicone.

2. Key Specifications & Technical Characteristics

• Material composition: Natural latex rubber (core) with medical-grade silicone elastomer outer coating; 100% latex-free balloon inflation channel (non-latex valve)

• Purity / biocompatibility: ISO 10993 certified; non-cytotoxic, non-pyrogenic, ≤ 0.5 EU/mL endotoxin limit

• Physical characteristics:

  • Fr size: 14Fr (4.7 mm outer diameter)

  • Balloon capacity: 10 cc (nominal), 5–15 cc functional range

  • Color: translucent amber core with smooth, clear silicone surface

  • Tip type: round, 2 opposed drainage eyes

  • Tensile strength: ≥ 12 N (balloon neck)

• Packaging options:

  • Individual peel-open sterile pouch (ethylene oxide sterilized)

  • Bulk inner carton: 50 units

  • Master case: 200 units (4 inner cartons)

  • Custom sterile procedure trays available on request

• Shelf life: 5 years from date of manufacture when stored in original packaging at 10–25°C, away from direct sunlight and moisture

3. Core Industrial Applications

• Primary industries: Acute care hospitals, long-term care facilities, urology clinics, medical device distributors, government tenders (public health systems), and humanitarian aid logistics

• Specific use cases:

  • Post-operative urinary retention (general surgery, orthopedics, gynecology)

  • Critical care fluid balance monitoring (ICU)

  • Neurogenic bladder management (spinal cord injury, multiple sclerosis)

  • Palliative care and immobile patient populations

• Performance vs. alternatives:

  • vs. uncoated latex catheters: 40% lower friction coefficient during insertion/removal; reduced latex protein leachables

  • vs. full silicone catheters: 60% lower material cost with comparable indwelling duration (up to 29 days) in low-encrustation patients

• Efficiency / durability advantage: The 2-way design enables closed irrigation without catheter exchange; silicone coating delays biofilm formation, extending average dwell time by 3–5 days compared to bare latex in clinical trials

4. Competitive Advantages

• Quality consistency: Manufactured under ISO 13485 and FDA 21 CFR 820 with batch-level sterility testing; < 0.1% defect rate over 24 rolling months

• Supply reliability: Dual-continent production redundancy (Asia + LATAM) with buffer stock of 2M+ units available for expedited 7-day global dispatch

• Logistics capability: Temperature-controlled supply chain validated for 30°C extreme transits without degradation

• Price competitiveness: Tiered pricing delivers 15–22% savings vs. leading brands (Bard, Hollister) at identical 14Fr/10cc balloon specifications

• Sustainability: Reduced latex protein processing; packaging shift to 30% recycled PET trays (by 2026 compliant)

• Technical support: Full IFU, MSDS, sterility validation reports, and regulatory dossier (CE MDR, UKCA, WHO prequalification path available)

5. Commercial & Supply Information

• Minimum order quantity (MOQ):

  • Sample order: 200 units (1 master case)

  • Standard commercial order: 10,000 units

  • Contract tender: 100,000 units

• Bulk loading capacity: 20 MT (20-foot container)

  • Equates to approx. 1,200,000 units per 20’ container, based on 13g unit weight + 4kg per inner carton + 18kg per master case → 20,000 kg net product weight

• Loading capacity per 40’ HC container: 25 MT product weight (1,500,000 units), utilizing high-density palletization