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FDA 510K/En14683 Decorative Surgical Face Mask

China FDA 510K/En14683 Decorative Surgical Face Mask, Find details about China Mask, Face Mask from FDA 510K/En14683 Decorative Surgical Face Mask

Model NO.
WM-FM030
Certificate
Ce, ISO 13485, FDA 510(K)
Sterile
Nonsterile
Material
Non-woven Fabric
Certification
CE, FDA, ISO13485
Ethylene Oxide Sterilization
Without Ethylene Oxide Sterilization
Quality Guarantee Period
Two Years
Logo Printing
With Logo Printing
Group
Adult & Child
Trademark
WM
Transport Package
50PCS/Box, 40boxes/CTN
Specification
Adult: 17.5*9.5cm; Child: 14.5*9.5cm
Origin
Jiangsu, China(Mainland)
HS Code
63079000
Model NO.
WM-FM030
Certificate
Ce, ISO 13485, FDA 510(K)
Sterile
Nonsterile
Material
Non-woven Fabric
Certification
CE, FDA, ISO13485
Ethylene Oxide Sterilization
Without Ethylene Oxide Sterilization
Quality Guarantee Period
Two Years
Logo Printing
With Logo Printing
Group
Adult & Child
Trademark
WM
Transport Package
50PCS/Box, 40boxes/CTN
Specification
Adult: 17.5*9.5cm; Child: 14.5*9.5cm
Origin
Jiangsu, China(Mainland)
HS Code
63079000
FDA 510k/EN14683 Decorative Surgical Face Mask
Product Description
NameFDA 510K/EN14683 decorative surgical face mask

Structure
3-ply: SBPP+MB+SBPP
with face visor or without
with soft foam or without

Style		earloop
Nose clipsingle nose wire
double nose wire
plastic nose clip
aluminum nose clip

Size		Adult: 17.5*9.5cm
Child: 14.5*9.5cm

Color		white/blue/green/yellow/as requested
 

Standard Class
Bacteria Filtration Efficiency (BFE)
Breathing Resistance 
(mmH2O/cm2)
Splash Resistance
(mmHg)
Particluate Filtration Efficiency (PFE)

FDA 510 (K)
>99%
<5.0
120/160
>99%

 
 
EN14683
Type I
>98%
<3.0
N/A
N/A

Type IR
>98%
<5.0
120
N/A

Type II
>99%
<3.0
N/A
>98%

Type IIR
>99%
<5.0
120/160
>98%


Packing: 50pcs/box, 40boxed/ctn
Delivery time: 15-30days after receipt of deposit payment
Shipping Port: Shanghai

Our Services
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.

Company Profile
Founded in 2006            
Specialized in disposable medical & PPE products          
Own 1500 m2 of clean room 
Provide OEM service    
Annual sales revenue > USD 10 million                                     
ISO 13485 certificated
FDA registered                
510K approved (No: K101000)                                                      
CE certificated

Our Advantage: 
1.FDA, FDA 510K, 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.

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