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    The face of mask exportsChina's standards are suddenly

    Apr 02, 2020 The United States has changed from the previous recognition of Chinese mask standards to rejection. As of 8:00 on March 31, Beijing time, there were more than 60,000 newly confirmed cases of new coronary pneumonia abroad, and a total of 680,000 confirmed cases. Among them, the total number of confirmed cases in the United States exceeds 160,000.

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    Surgical masks and N95 masks for medical purposes not listed in the United States when importing from China, whether they are manufacturers in the United States or abroad, can apply for emergency authorization. The following information needs to be submitted and sent to the FDA mailboxCDRH COVID19 SurgicalMasks@fda.hhs.gov.

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    Apr 04, 2020 FDA Guidance on KN95 Masks. There are rumors that several delays and/or FDA refusals of KN95 mask shipments are occurring. FDA is using the CDC Strategies for Optimizing the Supply of N95 RespiratorsCrisis/Alternate Strategies information to expand access, which includes KN95s. The Center for Devices is updating FDAs website to indicate this, but the approach is in effect now.

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    Select 5 respirators from each shipment you want to test. We need multiple respirators in order to ensure test results are accurate. Masks eligible for testingfiltering facepiece respirators such as N100, P100, R100, N99, P99, R99, N95, P95, R95, KN100, KP100, KN95, and KP95.

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