Disposable Medical Face Mask Type IIR

Description

1. Product Overview

The Disposable Medical Face Mask Type IIR is a high-barrier, fluid-resistant surgical mask engineered for critical healthcare environments. Its primary industrial application lies in hospitals, clinics, and laboratory settings where protection against infectious aerosols and blood-borne fluids is mandated. The key value proposition is superior bacterial filtration efficiency (BFE ≥98%) and splash resistance, ensuring compliance with stringent EU medical device regulations (EN 14683:2019+AC:2019). In a post-pandemic market landscape defined by supply chain resilience and infection control standardization, this product is strategically indispensable for institutional buyers seeking to mitigate liability, safeguard workforce health, and maintain operational continuity.

2. Key Specifications & Technical Characteristics

• Material Composition:

  • Outer layer: 100% high-density spunbond polypropylene (fluid-repellent)

  • Middle layer: Melt-blown polypropylene microfilter (≥99% BFE at 3.0μm)

  • Inner layer: Soft hypoallergenic spunbond polypropylene

  • Nose bridge: Adjustable, fully embedded aluminum strip

  • Ear loops: Textured, latex-free elastic cord

• Purity / Grade: Medical Grade Type IIR per EN 14683:2019

• Physical Characteristics:

  • Form: 3-ply flat-fold (pleated expansion design)

  • Color: Medical blue (outer), white (inner)

  • Particle size retention: ≥98% bacterial filtration efficiency at 3.0μm

  • Differential pressure (breathability): <6.0 Pa/cm²

  • Fluid resistance: ≥120 mmHg (synthetic blood splash resistance)

  • Microbiological cleanliness (bioburden): ≤30 CFU/g

• Packaging Options:

  • 50 masks / inner polybag

  • 10 inner bags / carton box (500 masks)

  • Master carton: 12 boxes (6,000 masks) per industrial pallet

• Shelf Life: 3 years from date of manufacture (when stored at -20°C to +40°C, <80% RH)

3. Core Industrial Applications

• Primary Industries: Acute care hospitals, surgical centers, dental clinics, diagnostic laboratories, long-term care facilities, and pharmaceutical manufacturing cleanrooms.

• Specific Use Cases:

  • Operating theaters (splash-prone procedures)

  • Isolation wards (airborne + droplet precautions)

  • High-volume testing sites (swab collection)

  • Emergency departments (intubation, suctioning, wound irrigation)

• Performance Advantage over Alternatives:

  • Unlike standard Type I or II masks, Type IIR provides proven fluid resistance — critical when blood or saliva jetting is a risk.

  • Melt-blown core maintains >99% BFE even at high humidity (4+ hours use), whereas cheaper electrostatic alternatives degrade rapidly.

  • Low pressure drop reduces clinician fatigue during long surgeries, improving compliance and reducing replacement frequency.

Cost efficiency: Higher per-unit cost offset by reduced mask changes (fewer breach incidents) and lower infection-related liability.

4. Competitive Advantages

• Quality Consistency: Statistical process control (SPC) on every batch; third-party tested quarterly to EN 14683. Inter-batch BFE variation <0.5%.

• Supply Reliability: Redundant manufacturing lines across two ISO 13485-certified facilities; 99.6% on-time delivery rate over 18 months.

• Logistics Capability: Dedicated ambient-temperature supply chain with real-time track-and-trace for pallet-level inventory.

• Price Competitiveness: Vertical integration from polypropylene raw material purchase to finished mask — 12–15% below EU/US regional spot prices at 20MT order volume.

• Sustainability: Outer/inner layers use 30% post-industrial recycled polypropylene; packaging 100% recyclable cardboard.

• Technical Support: Full regulatory dossier (CE marking, Declaration of Conformity, IFU, stability study) available within 24 hours of NDA execution.

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ): BULK 20MT (metric tons)
  Equivalent approx. 4.5–5.0 million masks depending on pack density.

• Loading Capacity per 20FT Container: 20MT
  Configuration: Master cartons palletized (24 pallets per container), shrink-wrapped and strapped for vertical stacking.

For pricing, delivery terms (FOB/CIF/CPT), and dynamic inventory allocation, proceed to RFQ.