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FDA 510K/EN 14683 Surgical Face 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
  • EN14683 /ISO13485/FDA
  • WM
  • Tie-On/earloop
  • Jiangsu, China(Mainland)
  • 50pcs/box, 40boxes/CTN
  • 200,000pcs
  • 30 days
  • T/T
  • 10,000,000pcs/month
  • FDA 510K/EN 14683 Surgical Face Mask
Name:FDA 510K/EN 14683 Surgical Face 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
face mask detail
wellmien FDA 510K surgical mask

EN 14683 surgical mask
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