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The Medical Devices Directive (MDD) applies to medical devices to be placed in the EU market, as such, surgical masks, which are mainly designed to protect the patient, fall under the scope of the MDD. The directive sets requirements for face surgical masks such as testing procedure, classification, safety performance and more concerning the

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2  · A standard N95 respirator is a tight fitting respiratory protective face mask, designed to help reduce the users exposure to airborne particles including very small particles (0.3 microns) and large droplets. N95 respirator face mask literally has a filtration efficiency of

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Yangzhou Vench Medical Products was established in 2012, as a manufacturer and exporter of a wide range of disposable medical products such as non woven disposable masks, N95 surgical cone masks, disposable mask with transparent visors, surgical drapes, overalls, capes, tapes, bandages, and medical

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The current standard ASTM F2100 11 (2011) specifies the performance requirements for Medical Face Masks with five basic criteria1. BFE (Bacterial Filtration Efficiency)BFE measures how well the medical face mask filters out bacteria when challenged with a bacteria containing aerosol. ASTM specifies testing with a droplet size of 3.0 microns

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For surgical face masks, fluid resistance is essential to prevent the transmission of infected blood and other body fluids. Surgical masks must be tested for fluid resistance according to the ASTM F1862 standard. ASTM F1862 provides standard test methods for the resistance of fluid penetration.

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