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 approved by the Food and Drug Administration (FDA) as surgical masks, via the 510(k) Premarket Authorization process.

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. You can find more information at About KN95 Masks.

Examples of particulate-filtering facepiece respirators.

Our policy for particulate-filtering facepiece respirators

Amazon requires that all particulate-filtering facepiece respirators have been tested to and comply with the specific regulations or standard requirements listed below:

Product	Regulation/Standard requirements
Particulate-filtering facepiece respirators (N95, N99, N100, R95, P95, P99, P100)	42 CFR Part 84(Approval of Respiratory Protective Devices); or FDA Emergency Use Authorization
Surgical N95 masks	FDA 510(k) Premarket Notification, 21 CFR Part 807 (FDA Establishment Registration); and 42 CFR Part 84 (Approval of Respiratory Protective Devices); 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 that 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 that you list
• Product packaging images for all particulate-filtering facepiece respirators that you list (images must include all six-sides of the product packaging)
• Product images for all particulate-filtering facepiece respirators that you list (images must include model number and compliance markings)
• Documentation that confirms that your product was either approved by NIOSH or approved by the FDA under Emergency Use Authorization
• For Surgical N95 Masks only, documentation that demonstrates all of the following:
  • FDA Establishment Registration number – screenshot
  • FDA 510(k) Premarket Notification – FDA Approval Letter

Some labs provide special Amazon rates for testing. To find more information about these providers, visit the Service Provider Network.

How to submit information

If we contact you for compliance documents, complete the following steps to submit the requested information:

1. In Seller Central, select the 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.

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, your listing privileges, or both
• 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

• Amazon services business solutions agreement
• Remove inventory overview
• Fix stranded inventory
• NIOSH-Approved Particulate Filtering Facepiece Respirators
• FDA Emergency Use Authorization

Disclaimer: The information provided on this page does not, and is not intended to, constitute legal advice. All information, content, and materials available on this site are for general informational purposes only.