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Ce and FDA 510K Approved Disposable Surgical Masks

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Diamond Member Since 2007

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Rating: 5.0/5
Manufacturer/Factory, Trading Company

Basic Info.

Model NO.
WM-FM050
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
Transport Package
50PCS/Box, 40boxes/CTN
Specification
Adult: 17.5*9.5cm; Child: 14.5*9.5cm
Trademark
WM
Origin
Jiangsu, China(Mainland)
HS Code
63079000
Production Capacity
9000000PCS/Month

Product Description

CE and FDA 510k Approved Disposable Surgical Masks
Product Description
NameCE and FDA 510K approved disposable surgical masks

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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