FDA 510K/EN14683 Surgical Face Masks
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
K. Non-sterile
L. For single use
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.
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.
| 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 |
Description :
Keep Safe: These Face masks are class 1 medical devices, and can be used for healthcare use, but should not be used in surgical or high risk situations, or where there is a high risk of contact with liquids or infectious materials.
Comfort & Breathable: Made with non-woven fabric for effective airway protection from small particles and droplets. Soft, non-irritating, comfortable and breathable. Adjustable earloop and nose clip fits for most of faces. Perfect for men, women, adults.
Care: Protect ourself and our loved ones with this disposable face masks in various environments such as home, office, school, gardening, construction, and also the work places as other public areas to help protect from allergens, dust and germs.
One Time Use: All these disposable masks are not recommend washable or reusable but for one time use and recommend to replace by each 4 hours.
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