Disposable and PP Material FDA 510k Certified 3-Ply Medical Surgical Face Mask
Description:
Our non-woven face mask is made up of top-grade non-woven fabric. The common size what we produced is 175*95mm, or customize, BFE degree is 99%, which depends on the material. We can also produced the face mask as per customer's requirements.
Characteristics:
1. Conform to FDA 510K(No: K101000), Conform to EN14683, Type IIR.
2. High 99% BFE and low breathing resistance for protection against airborne particles, splatter of blood saliva.
3. Unique surface water resistance and soft lining.
4. Non-irritating and glass fiber free.
5. Elastic: Latex free(round type).
6. Large binding anti-sliding totally.
7. Nose piece: Aluminum/iron nose wire.
8. Resistance to penetration by synthetic blood-120mmHg.
9. SBPP+MB+SBPP/ES/PAPER for 3 ply face mask.
10. Breathing Resistance (Delta P)<5.0.
Sample Policy:
1. Sample according to your design drawing. Sampling time: 3-5days.
2. Design your own sample, then remake it.
3. Existing Samples Sampling time: 1day.
4. Make mass production after your confirm the sample.
About Us:
Wellmien is a company specializing in the manufacture and trade of disposable medical products and personal protection equipments (PPT). Our company has implemented a strict quality management (QMS) and has passed ISO13485 certification. Our main products have passed CE Certification of European Union(EU) and FDA registration of USA. Wellmien surgical masks meet EN14683 standards of EU, and also have acquired FDA 510K approval of USA. With Superior products and services, our company had been winning the trust and support of new and old customers.
Our Advantage and Service:
1. FDA 510K(No: K101000), EN14683, TYPE IIR, CE, ISO13485
2. One-stop service: Excellent disposable medical products, personal protection equipments.
3. Welcome any OEM requirements.
4. Qualified products, 100% new brand material, safe and sanitary.
5. Offered free samples.
6. Professional shipping service if necessary.
7. Full Series after sales service system.
| Standard Class |
Bacterial Filtration Efficiency(BFE) |
Breathing Resistance(mmH20/cm2) |
Splash
Resistance(mmHg) |
| Type I |
>98% |
<3.0 |
N/A |
| Type IR |
>98% |
<5.0 |
120 |
| Type II |
>99% |
<3.0 |
N/A |
| Type IIR |
>99% |
<5.0 |
120 |
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