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FDA changes course and allows China's KN95 mask to be …

Apr 03, 2020 · (CNN) The US Food and Drug Administration on Friday changed its position on a sought-after type of respirator from China, the KN95, announcing that the agency will authorize the mask for use in...

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Apr 03, 2020 · The Food and Drug Administration (FDA) will no longer block the import of KN95 masks, due to a shortage in personal protective equipment, or PPE, in …

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Contains Nonbinding Recommendations Enforcement ... …

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Introduction

U.S. Pulls Authorization for Use of Face Masks Made in China

May 07, 2020 · The Food and Drug Administration reversed a decision to allow the emergency use of dozens of N-95 face masks made in China, after government testing found many didn’t work properly.

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Apr 02, 2020 · The Chinese-certified KN95 mask is designed to similar standards as the N95 — which is certified by the National Institute for Occupational Safety and Health — yet is currently cheaper and far more abundant.

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The U.S. Food and Drug Administration has removed its Emergency Use Authorization for several KN95 masks, which are made in China, after they failed to meet a minimum particulate filtration efficiency of 95% in National Institute for Occupational Safety and Health testing. During a public health emergency, the FDA can authorize the use of medical products that have not gone through the regular ...

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Jul 16, 2020 · Shoddy Surgical Masks Often Bear Bogus FDA Certificates : Shots - Health News Companies that made hats, socks and teddy bears have started producing surgical masks to protect people from COVID-19 ...

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Jul 25, 2020 · DONY face mask has permission to export to the US, EU market. DONY face mask got the FDA certification to export to US market. We also get the CE certification to export to EU market. Beside export permit per market, the DONY face mask has the ISO 9001:2015 The Quality Management System for our production processes and quality control.

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