Customization: | Available |
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Standard: | EN14683-2019 |
Filter Rating: | Normal |
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Attribute | Details |
Material | 3 layers (Outer: spunbond nonwoven, Middle: melt-blown, Inner: soft nonwoven) |
Style | Tie-on (four ties, two upper and two lower) |
Size | 17.5 x 9.5 cm |
BFE (Filtration) | ≥ 98% (Bacterial Filtration Efficiency) |
Color | Blue, green, white, or customized |
Sterility | Available in sterile and non-sterile options |
Packaging | 50 pcs/box, 2000 pcs/carton or customized |
Certifications | CE, ISO13485, EN14683 Type I/II/IIR |
Shelf Life | 2 years |
Secure Tie-On Design
Provides a custom and secure fit behind the head, ideal for surgical or long-wear scenarios.
High Filtration Efficiency
Middle melt-blown layer offers ≥98% BFE, reducing the risk of infection transmission.
Comfortable for Long-Term Wear
Soft inner layer protects sensitive skin; breathable for all-day use.
Sterile Option Available
Suitable for use in operating rooms and sterile environments.
Latex-Free & Hypoallergenic
Safe for most skin types and users with latex allergies.
Reliable protection for medical staff and patients
Tie-on design stays secure during procedures
Compliant with hospital and surgical standards
Customizable with OEM logo and packaging
Factory direct with competitive wholesale pricing
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 |