Disposable Mask for Adults
Meets CE/FDA Standards | 99% BFE Efficiency | Made in 100,000-Class Clean Room
Bestseller
CE Certified
FDA Registered
SGS Tested
Key Features
- 99% Bacterial Filtration Efficiency (BFE)
- Low Breathing Resistance (Delta P ≤ 5.0)
- Latex-Free & Hypoallergenic Materials
- 120 mmHg Fluid Resistance
- Made in 100,000-Class Clean Room
Product Details
Technical Specifications
| Parameter | Specification | Test Standard |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥ 99% | ASTM F2101-14, EN 14683:2019 |
| Particle Filtration Efficiency (PFE) | ≥ 99% | ASTM F2299 |
| Viral Filtration Efficiency (VFE) | ≥ 99% | ASTM F2101-14 |
| Breathability (Delta P) | ≤ 4.0 Pa | MIL-M-36954C |
| Splash Resistance Pressure | ≥ 16.0 kPa | ISO 22609:2004 |
| Microbial Cleanliness | ≤ 1 cfu/g | EN 14683:2019 |
| Material Composition | 3-layer non-woven fabric | - |
| Outer Layer | Blue/White/any color spunbond, 25 gsm, hydrophobic | - |
| Middle Layer | Meltblown filter, 20 gsm | - |
| Inner Layer | Blue/White/any color spunbond, 25 gsm, skin-friendly | - |
| Nose Bridge | Adjustable aluminum strip, 70mm | - |
| Ear Loops | Latex-free elastic, 17cm length | - |
| Size | 175 ± 5 mm × 95 ± 5 mm | - |
| Weight | 3.5 ± 0.5 g/piece | - |
| Clean Room Class | ISO 14644-1 Class 8 (100,000-class) | ISO 14644-1 |
Features & Benefits
High Protection
99% BFE/PFE/VFE efficiency provides reliable protection against bacteria and particles.
Breathable Comfort
Excellent wearing comfort, meets the high comfort index of "Low Breathing Resistance (ΔP ≤ 5.0 Pa).
Hypoallergenic
Latex-free materials suitable for sensitive skin and allergy sufferers.
Fluid Resistant
Resists penetration from bodily fluids, splashes, and sprays.
Adjustable Fit
Metal nose bridge can be adjusted for a secure, comfortable seal.
Quality Manufacturing
Produced in 100,000-class clean room for consistent quality.
Certifications & Compliance
CE Certified
Medical Device Regulation (EU) 2017/745
Classification: Class I
FDA Registered
Establishment Registration Number: 3018283399
Device Listing Number: D435546
SGS Tested
Report No.: QIP-ASI2141374
Test Date: 2021-09-22
ISO 9001:2015
Quality Management System Certified
Certificate No.: 93125Q1665ROM
Packaging Options
Applications
This 3-ply surgical mask is suitable for various applications:
Healthcare Settings
Hospitals, clinics, dental offices, and other medical facilities
Medical Professionals
Doctors, nurses, dentists, and healthcare workers
General Public
Daily protection in crowded places, public transportation, offices
Industrial Use
Manufacturing, construction, and industrial environments
Educational Institutions
Schools, universities, and training centers
Retail & Service
Retail stores, restaurants, hotels, and service industries
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