Disposable FDA 510k/En14683 Clear Cough Surgical Medical Face Masks

• Customization: Available
• Standard: EN14683-2019
• Filter Rating: Normal
• Model NO.: WELLMIEN-FM001
• Available Times: Disposable
• Type: Medical Surgical Mask
• Layers: 3 Ply
• Style: Earloop
• Shape: Flat
• Sterilization: as Customized
• Age Group: All
• Color: White/Blue/Green/Yellow etc.
• Size: Adult: 17.5*9.5cm / Child: 14.5*9.5cm
• Layer: 3ply
• Nose Clip: Single Nose Wire/Double Nose Wire/Plastic Nose Cli
• 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, 40boxs/CTN
• Specification: Adult: 17.5*9.5cm; Child: 14.5*9.5CM
• Trademark: WM
• Origin: Jingsu, China(Mainland)
• HS Code: 63079000
• Production Capacity: 9000000PCS/Month

Product Description

Disposable FDA 510k/En14683 Clear Cough Surgical Medical Face Masks

Product Description
Name	disposable FDA 510K/EN14683 clear cough surgical medical face masks
Structure	3-ply: SBPP+MB+SBPP with face visor or without with soft foam or without
Style	earloop
Nose clip	single 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)	Particulate 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 you confirm the sample.

Company Profile
Founded in 2006            
Specialized in disposable medical & PPE products          
Own 1500 m2 of cleanroom 
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 equipment.
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.