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EN14683 Surgical Mask/ FDA 510k Bacteria Breathing Surgical Mask

Color: Blue, Yellow, Green or as requested
Size: 17.5X9.5cm, 14.5X9.5cm
Material: 100% SBPP
Sales Models: Wholesale
MOQ: 200000PCS

  • WM
  • 63079000

Name: EN14683 Surgical Mask/ FDA 510k bacteria breathing surgical mask

Style earloop or tie on
Size 17.5*9.5cm, 17.5*9.0cm, 18.0*9.0cm
Material SBPP,MB,SBPP for 3-ply
Certification FDA, CE, ISO13485
Structure with face visor or without
Type with soft foam or without
Nose clip single nose wire
double nose wire
plastic nose clip
aluminum nose clip

1.Conform to FDA510K(No:K101000).

2.Glass fiber free and latex free.

3.Breathing Resistance (Delta P)<5.0.

4.Fluid resistant layer with unique single pleated design to prevent fluid pooling.

5.Distinguished with appearance: sewing edge; folded edge; auto edge.

6.Bacterial Filtration Efficiency (BFE%) >99% ,Particle Filtration Efficiency(PFE%)>99%.

7.Resistance to penetration by synthetic blood 160mmHg.

face mask (1)

face mask

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. Sampling time:3-5days .
2. Existing Samples Sampling time:1day
3. 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.

+86 512 6595 3508
+86 512 6595 3928


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