Customization: | Available |
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Type: | Face Mask/Apron/Gloves |
Material: | Non-woven Fabric |
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Attribute | Details |
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Material Composition | 3 layers of nonwoven fabric: Outer layer (PP), Middle filter layer (Melt-blown PP), Inner layer (PP) |
Fabric Type | Spunbond Polypropylene (PP) and Melt-blown Polypropylene |
Bacterial Filtration Efficiency (BFE) | ≥ 95% or ≥ 98% - Available in standard and high-protection levels |
Particle Filtration Efficiency (PFE) | ≥ 95% - Filters airborne particles effectively |
Earloop Style | Elastic, latex-free earloops for a secure, comfortable fit |
Nose Clip | Adjustable metal or plastic nose bridge for a secure fit |
Breathability (ΔP) | ≤ 29.4 Pa/cm² - Ensures easy and comfortable breathing |
Size Options | 17.5 cm x 9.5 cm (Adult) 14.5 cm x 9 cm (Kids) - Custom sizes available |
Color Options | Blue, White, Black, Pink, Green - Customizable colors available |
Sterility | Non-sterile (standard) and sterile options available |
Packaging Options | 50 pcs/box, 2,000 pcs/carton - Custom packaging available |
Certifications | CE, ISO 13485, FDA, EN 14683 Type I/II/IIR - Compliant with international standards |
Shelf Life | 2-3 years under proper storage (cool, dry environment) |
Intended Use | Single-use, disposable; not for surgical or medical invasive procedures (unless specified) |
Printing & Branding | Custom logo printing available for branding and marketing purposes |
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 |