EUA Intended Use and Other Instructions for SHX01
On Jul 20, 2020, the Food and Drug Administration (FDA) has added our respirator model SHX01 as an authorized respirator to the Emergency Use Authorization (EUA) for non-NIOSH-approved filtering facepiece respirators manufactured in China.
The documents below are the formal approval letter of our EUA application, electronic labeling condition, and additional information about our product.
The EUA Letter of Authorization is available at, https://www.fda.gov/media/136664/download.
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EUA Approval Letter