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This article applies to selling in: United States

Particulate filtering facepiece respirators

If you list products on our store, you must comply with all federal, state, and local laws and our policies applicable to those products and product listings, including this policy.

Particulate filtering facepiece respirators covered by this policy

A Particulate filtering facepiece respirator (PFFR) is a disposable respirator that covers the nose and mouth. It filters out airborne particles including dust and fumes. There are seven classes of PFFRs approved by the National Institute for Occupational Safety and Health (NIOSH), including N95, Surgical N95, N99, N100, R95, P95, P99, and P100. Surgical N95 masks are NIOSH-approved N95 masks that are also cleared by the Food and Drug Administration (FDA) as surgical masks.

In light of COVID-19, the FDA has issued an Emergency Use Authorization (EUA) for KN95 masks. KN95 is a Chinese standard for respirator masks. Similar to the N95 standard, masks must filter 95% or more of particles to meet the KN95 standard. For more information see: About KN95 Masks

Examples of particulate filtering facepiece respirators

Our policy for particulate filtering facepiece respirators

Amazon requires that particulate filtering facepiece respirators have been tested and meet the specific regulations or standard requirements listed below for all particulate filtering facepiece respirators you list:

Product Regulation/Standard requirements
Particulate filtering facepiece respirators (N95, N99, N100, R95, P95, P99, P100)
  • 42 CFR Part 84 or
  • FDA Emergency Use Authorization
Surgical N95 masks
  • 21 CFR 878.4040 and
  • 42 CFR Part 84 and FDA Establishment Registration; or
  • FDA Emergency Use Authorization
KN95 masks FDA Emergency Use Authorization

Required information

We may request this information from you at any time so we recommend you have it easily accessible:
  • Your company name (if applicable) and seller ID
  • Your contact information: email address and phone number
  • A list of all particulate filtering facepiece respirators you list
  • Product packaging images for all particulate filtering facepiece respirators you list. The image must include all six-sides of the product packaging.
  • Product images for all particulate filtering facepiece respirators you list. Images must include all relevant:
    • Safety information
    • Compliance markings
    • Product hazard warnings
Some labs provide special Amazon rates for testing. To find more information about these providers, visit the Seller Central Service Provider Network page.

How to submit information

If you are contacted by us for compliance documents, complete the following steps to submit the requested information:
  1. In Seller Central, select Performance tab, and choose Account Health.
  2. Under Product Compliance Requests in the bottom right corner of the page, click Documentation Requests.
  3. Click Provide Documentation or Appeal next to the product.
  4. Select No to upload documents.
  5. Follow the steps in the Submit required documents section.
Note: Test Reports must contain images of the tested products including packaging, compliance markings, warning labels and age grading if applicable. The product images on the test reports must show that the product is the same when compared to the product images on the detail page.

Policy violations

If you do not provide the required information by the applicable deadline, we may:
  • Remove the relevant product listings
  • Suspend your ability to add new products and/or listing privileges
  • Withhold any payments due to you
  • Pursue legal action
We reserve the right to take any further actions that may be necessary in our sole discretion.

Additional resources

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