Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks

Product Details
Customization: Available
Type: Face Mask/Apron/Gloves
Material: Non-woven Fabric
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Management System Certification
ISO 13485
Export Year
2006-05-15
  • Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks
  • Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks
  • Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks
  • Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks
  • Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks
  • Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks
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Basic Info.

Model NO.
WELLMIEN-FM0043
Ethylene Oxide Sterilization
Without Ethylene Oxide Sterilization
Quality Guarantee Period
Two Years
Group
Adult & Child
Logo Printing
With Logo Printing
Size
Adult: 17.5*9.5cm / Child: 14.5*9.5cm
Layer
3ply
Style
Earloop
Color
White/Blue/Green/Yellow etc.
Nose Clip
Single Nose Wire/Double Nose Wire/Plastic Nose Cli
Certificate
Ce, ISO 13485, FDA 510(K)
Sterile
Nonsterile
Transport Package
50PCS/Box, 40boxs/CTN
Specification
Adult: 17.5*9.5cm; Child: 14.5*9.5CM
Trademark
WELLMIEN or OEM
Origin
Jingsu, China(Mainland)
HS Code
63079000
Production Capacity
9000000PCS/Month

Product Description

Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks
Disposable FDA 510k/En14683 Breathing Bacteria Medical Face MasksDisposable FDA 510k/En14683 Breathing Bacteria Medical Face MasksDisposable FDA 510k/En14683 Breathing Bacteria Medical Face MasksDisposable FDA 510k/En14683 Breathing Bacteria Medical Face MasksDisposable FDA 510k/En14683 Breathing Bacteria Medical Face MasksDisposable FDA 510k/En14683 Breathing Bacteria Medical Face MasksDisposable FDA 510k/En14683 Breathing Bacteria Medical Face MasksDisposable FDA 510k/En14683 Breathing Bacteria Medical 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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