Frequently Ask Questions

Non-NIOSH Respirators: are they allowed in the U.S.?

Yes, respirators approved under standards used in other countries, such as KN95, are allowed to be used in the US during the COVID-19 pandemic.

According to the FDA’s website:
“The U.S. Food and Drug Administration (FDA) is working diligently to mitigate any potential shortages in the supply chain and taking action to assure health care personnel on the front lines have sufficient supplies of respiratory protective devices. The FDA concluded, based on the totality of scientific evidence available, that certain imported respirators that are not National Institute for Occupational Safety and Health (NIOSH)-approved are appropriate to protect the public health or safety.

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What is EUA? Why is it needed for Non-NIOSH products in the U.S.?

During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.

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How do I know the masks you provide can protect me adequately?

We have been supplying local PPE suppliers, pharmaceutical laboratories, and the Brazilian Federal government with our masks. We entrusted SGS, a third-party, probably the most internationally renowned certifying body, to testify the legality and conformity of our products.

To further protect the consumers, the CDC offers the International Respirator Assessment that takes requests from federal and state agencies, employers, and healthcare systems to evaluate the quality of the masks. The evaluation conclusions following the assessment processes are legal binding and have on which been a basis to kick out any careless suppliers that fail to keep their quality commitment.

Can I reuse PPE?

According to FDA’s website:
“In general, most PPE is designed to be used only one time and by one person prior to disposal. There are a few exceptions, for example some types of elastomeric respirator masks and protective eyewear such as goggles may be reused if the user follows decontamination methods in the product labeling.

If PPE is exposed to infectious materials during use (e.g., body fluids from an infected person) the PPE is considered contaminated and the wearer should remove it promptly, using proper removal and disposal procedures. Please be aware that even if a PPE successfully protects you while it is being worn, improper removal and disposal of contaminated PPEs can expose the wearer and other people to infectious agents.”

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Can I wash disposable PPE?

According to FDA’s website:
“No. Disposable PPE is designed to be used only one time and by one person; it cannot be washed. Washing PPE changes its protective or barrier capabilities, and it may no longer be effective.”

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Do I have to pay in full upon ordering?

Generally, we ship each shipment with the cargo value you paid for.