Disposable FDA 510K/En14683 Comfortable Earloops & Noseclip Surgical Face Mask

• Customization: Available
• Type: Face Mask/Apron/Gloves
• Material: Non-woven Fabric
• Model NO.: WELLMIEN-FM165-A
• 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: WM
• Origin: Jingsu, China(Mainland)
• HS Code: 63079000
• Production Capacity: 9000000PCS/Month

Product Description

Disposable FDA 510K/EN14683 Comfortable Earloops & Noseclip Surgical Face Mask

Product Description
Name	Disposable FDA 510K/En14683 Comfortable Earloops & Noseclip Surgical Face Mask
	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)	Particluate Filtration Efficiency (PFE)
FDA 510 (K)	L1	>95%	<5.0	80mmHg	>95%
	L2	>98%	<6.0	120mmHg	>98%
	L3	>98%	<6.0	160mmHg	>98%
EN14683	Type II	>98%	<40Pa/cm2	>120mmHg	>98%
	Type IIR	>98%	<60Pa/cm2	>120mmHg	>98%

Packing: 50pcs/box, 40boxes/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.