Customization: | Available |
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Standard: | EN14683-2019 |
Filter Rating: | Normal |
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Attribute | Details |
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Material | Nonwoven fabric + Melt-blown fabric + Soft inner layer |
Layers | 3 layers - Outer hydrophobic layer, middle filtration layer, inner soft absorbent layer |
Filtration Efficiency | ≥95% (BFE) for bacterial filtration, blocks dust, droplets, and airborne particles |
Size | One-size fits most adults (17.5 cm × 9.5 cm) |
Color Options | Blue (Standard) - Other colors available upon request |
Earloop Style | Elastic soft earloops - Stretchable and non-irritating |
Nose Clip | Adjustable metal nose bridge - Enhances fit and reduces fogging for glasses wearers |
Breathability | High airflow design for easy breathing |
Skin-Friendliness | Hypoallergenic and latex-free - Suitable for sensitive skin |
Usage Type | Disposable - Single-use for hygiene and safety |
Certification | CE, FDA, ISO 13485 - Meets international medical and protective standards |
Packaging | 50 pcs/box, 2000 pcs/carton - Custom packaging available |
Applications | Medical, personal protection, workplace, travel, public spaces |
Customization | Logo printing, private labeling, and personalized packaging available |
3-Layer Protection: Shields against dust, bacteria, pollen, and airborne contaminants.
High Bacterial Filtration Efficiency (BFE ≥95%) - Provides medical-grade protection.
Breathable & Lightweight: Comfortable for extended wear without restricting airflow.
Soft Elastic Earloops: Ensures a secure yet gentle fit without ear discomfort.
Adjustable Nose Clip: Enhances sealing for a snug fit and reduces fogging for glasses.
Universal One-Size Fit: Suitable for most adult face shapes and sizes.
Hypoallergenic & Skin-Friendly: Free from latex and other irritants.
Disposable & Hygienic: Single-use to prevent cross-contamination.
FDA & CE Certified: Meets global quality and safety standards.
Customizable Branding Available: Ideal for businesses, hospitals, and organizations.
Prevents Airborne Contaminants: Acts as a protective barrier against dust, bacteria, and pollutants.
Minimizes Respiratory Exposure: Reduces exposure to allergens and airborne particles.
Comfortable for Long-Term Wear: Soft materials prevent irritation and skin discomfort.
Ideal for Crowded Public Areas: Helps reduce the spread of airborne particles in high-traffic environments.
Suitable for Sensitive Skin: Nonwoven fabric is gentle on the face and non-irritating.
Reduces Risk of Cross-Contamination: Disposable design ensures hygiene and safety.
Versatile for Daily Use: Effective for both professional and personal environments.
Bulk Order Savings: Cost-effective pricing for wholesale and institutional use.
Eco-Friendly Options Available: Biodegradable versions for sustainable solutions.
Packing:
Normal Packing | QTY (pc) |
Carton Size (cm) |
N.G (kg/ctn) |
W.G (kg/ctn) |
Prodution Time |
50pcs/box 40boxes/ctn |
200,000 | 52X40X36 | 7.5 | 8.5 | 10 |
700,000 (1X20GP) |
15 | ||||
1,440,000 (1X40GP) |
20 | ||||
1,720,000 (1X40HQ) |
20 | ||||
Remark: Production time is based on quantity and the time of order confirmation. |
Wellmien Performance for Surgical Face Mask ASTM Level 3 Non Woven FDA510K:
Standard Class |
Breathing Filtration Efficiency (BFE) |
Breathing Resistance (mmH20/cm2) |
Splash Resistance |
Particulate Filtration Efficiency (PFE) |
FDA 510K |
>99% |
< 6,0 |
160 |
>99% |
Shipping Port: Shanghai or Wuhan.
Packing Picture:
Remark: To better ensure the safety of your goods, professional, environmentally friendly, convenient and efficient packaging services will be provided.
FDA 510 K Requirements:
MEDICAL FACE MASK TESTS AND REQUIREMENTS U.S.A.: ASTM F2100-19 STANDARD SPECIFICATION FOR PERFORMANCE OF MATERIALS USED IN MEDICAL FACE MASKS |
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Test Item | ASTM F2100-19 | |||
Level 1 | Level 2 | Level 3 | ||
Barrier Testing | BFE% ASTM F2101 |
≥95 | ≥98 | |
PFE% ASTM F2299 |
≥95 | ≥98 | ||
Synthetic Blood ASTM F1862 |
Pass at 80mmHg | Pass at 120mmHg | Pass at 160mmHg | |
Physical Testing | Differential Pressure | <5.0 mmh2o=""> | <6.0 mmh2o=""> | |
Safety Testing | Flammablility 16 CFR Part 1610 |
Class 1 (≥ 3.5 seconds) | ||
Microbial Cleanliness ISO 11737-1 |
Not required | |||
Biocompatibility ISO 10993 |
510 K Guidance recommends testing to ISO 10993 | |||
Sampling ANSI/ASQC Z1.4 ISO 2859-1 |
1. AQL 4% for BFE,PFE, Delta P 2. 32 masks for Synthetic Blood (Pass=≥29 passing, Fail=≤28 passing) 3. 14 masks for Flammability |
Medical & Healthcare Use: Essential for hospitals, clinics, and dental offices.
Workplace & Office Protection: Ensures a clean and safe working environment.
Public Transport & Travel: Ideal for flights, buses, and crowded areas.
Retail & Customer Service: Suitable for shop assistants, hospitality staff, and customer-facing roles.
Personal Daily Use: Provides protection in shopping malls, supermarkets, and social gatherings.
Outdoor & Industrial Work: Shields against dust and airborne particles in construction sites and factories.
Educational Institutions: Recommended for teachers, students, and school staff.
Elderly & Immunocompromised Protection: Offers additional safety for vulnerable individuals.
Beauty & Wellness Industry: Commonly used in spas, salons, and tattoo studios.
Emergency Preparedness: A must-have for health kits and disaster readiness supplies.
Certified & Trusted Quality: Complies with FDA, CE, and ISO safety standards.
Superior Comfort & Fit: Designed for long-term wear without irritation.
Advanced 3-Layer Protection: Blocks harmful particles and airborne contaminants effectively.
Customizable & Private Labeling: Perfect for businesses and healthcare institutions.
Affordable & Cost-Effective: Competitive pricing for wholesale and bulk orders.
Fast Shipping & Reliable Supply: Large stock available for immediate dispatch.