High Filtration Medical Mask
Meets CE/FDA Standards | BFE/VFE/PFE ≥99% | Advanced 4-Ply Construction
Premium Grade
CE Certified
FDA Registered
SGS Tested
Key Features
- BFE/VFE/PFE ≥99% Filtration Efficiency
- 4-Ply Advanced Construction
- Low Breathing Resistance (Delta P ≤ 4.0)
- 160 mmHg Fluid Resistance (ASTM Level 3)
- Latex-Free & Hypoallergenic
- 0.1 Micron Particle Filtration
Product Details
Technical Specifications
| Parameter | Specification | Test Standard |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥ 99% | ASTM F2101-14, EN 14683:2019 Type IIR |
| Particle Filtration Efficiency (PFE) | ≥ 99% (0.1 micron) | ASTM F2299 |
| Viral Filtration Efficiency (VFE) | ≥ 99% | ASTM F2101-14 (Bacteriophage ΦX174) |
| Fluid Resistance | 160 mmHg | ASTM F1862 (Level 3) |
| Breathability (Delta P) | ≤ 4.0 mm H₂O/cm² | EN 14683:2019 |
| Flame Spread | Class 1 | 16 CFR Part 1610 |
| Material Composition | 4-layer non-woven fabric | - |
| Outer Layer | Hydrophobic spunbond, 30 gsm, fluid-resistant | - |
| Filter Layer 1 | Meltblown electret, 25 gsm, charged filtration | - |
| Filter Layer 2 | Meltblown reinforcement, 20 gsm | - |
| Inner Layer | Skin-friendly spunbond, 25 gsm, moisture-wicking | - |
| Nose Bridge | Adjustable aluminum strip, 90mm, double-core | - |
| Ear Loops | Latex-free elastic, 17cm, ultrasonic welded | - |
| Size | 175 ± 5 mm × 95 ± 5 mm | - |
| Weight | 4.2 ± 0.5 g/piece | - |
| Clean Room Class | ISO 14644-1 Class 8 (100,000-class) | ISO 14644-1 |
Features & Benefits
Triple ≥99% Protection
BFE, PFE, and VFE all exceed 99%, providing comprehensive protection against bacteria, particles, and viral aerosols.
4-Ply Construction
Dual meltblown layers with electret charging technology significantly enhance filtration while maintaining breathability.
ASTM Level 3 Fluid Resistance
160 mmHg fluid resistance meets the highest ASTM standard, ideal for surgical and high-risk medical environments.
Low Breathing Resistance
Delta P ≤ 4.0 mm H₂O/cm² ensures comfortable breathing even during extended wear periods.
Skin-Friendly Materials
Inner layer uses ultra-soft, hypoallergenic spunbond that is gentle on sensitive skin and latex-free.
Clean Room Manufactured
Produced in ISO Class 8 clean room with strict quality control and microbial cleanliness ≤ 1 cfu/g.
Technology & Filtration Principle
4-Ply Advanced Filtration Structure
1
Outer Layer
Hydrophobic spunbond prevents fluid penetration and blocks large particles.
2
Electret Meltblown
Charged fibers capture 0.1 micron particles via electrostatic attraction.
3
Reinforcement Layer
Secondary meltblown provides additional mechanical filtration barrier.
4
Inner Layer
Skin-friendly spunbond wicks moisture for all-day comfort.
Filtration Mechanism
Our high filtration medical mask employs a dual-mechanism approach: mechanical blocking and electrostatic adsorption. The outer hydrophobic layer blocks large droplets and particles (>10μm). The dual meltblown layers use electret-treated polypropylene fibers that carry a permanent electrostatic charge, effectively capturing sub-micron particles (0.1-1.0μm) through electrostatic attraction — significantly more efficient than pure mechanical filtration alone.
The BFE test (ASTM F2101) uses Staphylococcus aureus aerosol (3.0μm) to verify bacterial filtration. The PFE test (ASTM F2299) uses 0.1μm latex particles to validate sub-micron particle capture. The VFE test uses bacteriophage ΦX174 (0.027μm) to confirm viral aerosol protection. All three metrics achieving ≥99% demonstrates comprehensive barrier performance.
Quality Control
Every production batch undergoes rigorous testing including: BFE/PFE/VFE verification, differential pressure measurement, fluid resistance testing, and microbial cleanliness assessment. Test reports from SGS and independent laboratories are available for each batch.
Certifications & Compliance
CE Certified
Medical Device Regulation (EU) 2017/745
Classification: Class I (Type IIR)
FDA Registered
Establishment Registration: 3018283399
510(k) Exempt Surgical Mask
SGS Tested
Report No.: QIP-ASI2141374
BFE/PFE/VFE All ≥99% Verified
ISO 9001:2015
Quality Management System Certified
Certificate No.: 93125Q1665ROM
Applications & Use Scenarios
This high filtration medical mask is designed for high-risk medical and healthcare environments:
Surgical Operations
Operating rooms, invasive procedures, and surgical suites requiring ASTM Level 3 protection.
ICU & Isolation Wards
Intensive care units and infectious disease isolation areas with high airborne pathogen risk.
Dental & Oral Surgery
Dental clinics and oral surgical procedures with high fluid exposure risk.
Emergency & Trauma
Emergency departments and trauma centers with unpredictable exposure scenarios.
Clinical Laboratories
Microbiology labs, pathology departments, and specimen handling areas.
High-Risk Travel
Long-haul flights and travel through high-prevalence regions.
Packaging Options
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