En14638 Type IIR Disposable Medical Mask 3ply with CE Certification
Characteristics:
A. Conform to FDA 510K of the USA (NO: K101000)
B. Fluid splash resistance
C. Particle filtration efficiency (PFE) > 99%
D. Bacteria filtration efficiency (BFE) > 99%
E. Differential pressure (Delta-P) > 4.5 mm H2O/cm2
F. Class I none flammable
G. Biocompatile
H. Non- irritating
I. Glass fiber free and latex free
J. Adjustable nose piece for easy use
H. Non-sterile
I. For single use
Our Advantage:
1. CE, ISO13485 certification.
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.
Sample Policy:
Factory direct sale new breathing mask Protective masks general face mask
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.
Quality Control:
1. We will not start to make the products until you confirm the sample.
2. The packing will be water-proof, damp-proof and sealed.
| 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 |
Audited Supplier 
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