Customization: | Available |
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Type: | Surgical Supplies Materials |
Material: | Non-woven Fabric |
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Parameters:
Attribute | Details |
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Material | 3 Layers - Nonwoven (Outer), Meltblown (Middle), Soft Nonwoven (Inner) |
Type | Surgical / Medical Face Mask |
Style | Earloop Type / Pleated 3-Ply Design |
Size | 17.5 × 9.5 cm (Standard Adult Size) |
Color Options | Blue, White, Green, Pink, Black, Customized |
BFE (Bacterial Filtration) | ≥ 98% |
PFE (Particle Filtration) | ≥ 95% |
Fluid Resistance | Yes - Protects Against Droplets and Splashes |
Breathability | High - Comfortable for Prolonged Use |
Latex-Free | Yes |
Nose Clip | Adjustable Nose Bridge for Better Seal |
Sterility | Non-Sterile / Sterile Optional |
Usage Type | Single Use / Disposable |
Standards | EN14683 Type IIR / ASTM F2100 Level 2-3 (as required) |
Packaging | 50 pcs/box, 2000 pcs/carton (customized packaging available) |
OEM/ODM | Supported - Logo, packaging, colors |
Certifications | CE, ISO13485, FDA |
Samples | Free samples available |
Triple-Layer Protection:
3-ply structure with meltblown filtration layer.
High Filtration Efficiency:
≥98% BFE and ≥95% PFE - Protects against bacteria, viruses, dust, and other airborne particles.
Comfortable Fit:
Soft earloops and adjustable nose bridge reduce pressure on the ears and improve the seal.
Hypoallergenic & Latex-Free:
Safe for sensitive skin and users with latex allergies.
Lightweight & Breathable:
Easy to breathe even during extended wear - ideal for workdays or travel.
Fluid Resistance:
Helps block splashes, bodily fluids, and respiratory droplets - essential for medical environments.
Ideal for Medical & Surgical Use
Meets industry standards for hospital and clinical safety.
Hygienic Single-Use Protection
Disposable design minimizes contamination risks.
Comfort All Day Long
Breathable materials and ergonomic design ensure comfort during extended usage.
Universal Fit
Suitable for adults of all face shapes and sizes.
Custom Branding Available
Print your logo on the mask or packaging for brand visibility.
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 |
||||
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 |
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