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
Specification:
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.