Disposable Isolation Gown Level 3 Fluid Resistant

Description

1. Product Overview

The Disposable Isolation Gown Level 3 Fluid Resistant is a medical-grade barrier garment engineered for healthcare and industrial environments requiring intermediate protection against fluid penetration. Its primary use is in patient isolation, surgical support, and high-risk examination settings where exposure to blood, bodily fluids, or splash hazards is anticipated. The key value proposition is superior fluid resistance combined with breathable comfort, ensuring clinician safety without compromising mobility. Strategically, this product is critical for global health systems and PPE supply chains facing stringent regulatory standards and infection control mandates, offering a reliable, cost-efficient alternative to reusable gowns.

2. Key Specifications & Technical Characteristics

• Material Composition: Multilayer SMS (Spunbond-Meltblown-Spunbond) polypropylene; fluid-repellent treated outer layer

• Performance Grade: AAMI Level 3 — fluid resistance up to 50 cm H₂O pressure; passes ASTM F1670 (blood penetration) and ASTM F1671 (viral penetration)

• Physical Characteristics:

  • Color: Medical white or light blue

  • Form: Knitted cuffs, thumb-loop optional; back-closure with tie-straps

  • Particle filtration efficiency: >98% for 3-micron bacteria

  • Basis weight: 40–45 gsm

• Packaging Options: Sterile (individually wrapped) or non-sterile (20 gowns/bag, 5 bags/case)

• Shelf Life: 3 years in original packaging, stored at 0–40°C in dry conditions

3. Core Industrial Applications

• Primary Industries: Hospitals & surgical centers, clinical laboratories, dental clinics, pharmaceutical manufacturing, long-term care facilities, and emergency medical services (EMS)

• Specific Use Cases:

  • COVID-19/influenza isolation wards

  • Minor surgical procedures and wound care

  • Laboratory handling of non-airborne biological samples

• Performance Advantages:

  • Superior to Level 1 or 2 gowns for moderate fluid exposure (e.g., arterial line placement, irrigation)

  • More breathable and 30% lighter than reusable HDPE gowns, reducing heat stress

  • Cost-per-use 60–80% lower than reusable gowns when factoring in laundering and sterilization

• Efficiency/Durability: Single-use eliminates cross-contamination risk; reinforced raglan sleeves reduce tear rates by 35% vs. standard Level 3 gowns

4. Competitive Advantages

• Quality Consistency: Lot-to-lot ISO 13485 certified manufacturing; AAMI PB70 Level 3 audited quarterly by SGS

• Supply Reliability: 24/7 production lines across 3 geographically diverse plants; 99.2% on-time delivery rate for orders > 500,000 units

• Logistics Capability: Pre-consolidated palletization with 48-hour dispatch for stock items; expedited customs documentation (HS code 6210.10)

• Price Competitiveness: Tiered pricing reduces unit cost by 15–22% vs. European and North American equivalents at similar specifications

• Sustainability: 100% polypropylene recyclable via industrial partners; packaging uses 30% post-consumer recycled cardboard

• Technical Support: Full traceability reports, IFUs in 12 languages, and regulatory filing support (CE, FDA 510(k) exemption guidance)

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ):

  • Non-sterile: 10,000 units

  • Sterile: 25,000 units

• BULK 20MT Loading Capacity: Approx. 400,000 non-sterile gowns (20 gowns/bag, 5 bags/case → 100 gowns/case → 150 cases per pallet → 20 pallets per 20FT container; 20MT = 2 x 20FT containers)

• Container Utilization:

  • 20FT dry container: 400,000 units (~10 MT)

  • 40FT dry container: 800,000 units (~20 MT)