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Based on this comparison, it is reasonable to consider KN95(China GB2626-2006), KF94 (Korea KMOEL - 2017-64) as “equivalent” to N95 (United States NIOSH-42CFR84) and FFP2 (Europe EN 149-2001) respirators, for filtering non-oil-based particles such as those resulting from wildfires, PM 2.5 air pollution, volcanic eruptions, or bioaerosols (e.g. viruses).

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Buyer beware: Many brokers have rushed into the market and offer inferior quality masks that do not meet FDA import requirements and at price points per KN95 Mask that are significantly higher than pre COVID-19 levels. In some cases, profiteering “middle-men” have elevated the prices, with costs ranging from $4.50 up to $12 each. This April 3, 2020 article highlights some of the high ...

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Device Registration and Listing | FDA

FDA does not issue Registration Certificates to medical device establishments. FDA does not certify registration and listing information for firms that have registered and listed.

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Medical Devices and the COVID-19 (Coronavirus) Pandemic Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face ...

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SoMedical Supplies Co., Ltd. is a professional medical-surgical disposable protective supplies factory based-in China with 10 years of experience. We offer a variety of disposable protective products, such as disposable face masks, gowns, coverall, overall, SMS bed sheet, caps, shoe cover, etc.

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Medical Devices | FDA

Medical Devices and the COVID-19 (Coronavirus) Pandemic Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face ...

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April 30, 2020 | 9:00AM Hand Sanitizers are Available for order now Good news, our supply chain team managed to secure 120 bottles of Water-free Hand Sanitizer (70%+ Alcohol) today and they are in stock for order now. The hand sanitizers are made of 70%+ alcohol that kills 99.9% of …

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ASTM standards are referenced by the Food and Drug Administration (FDA), as the endorsed standard in the United States. The current standard ASTM F2100-11 (2011) specifies the performance requirements for Medical Face Masks with five basic criteria: 1.

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