Particulate-filtering facepiece respirators

If you list products in 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. The National Institute for Occupational Safety and Health (NIOSH), under the Centers for Disease Control and Prevention (CDC), approves PFFRs 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.

KN95 is a Chinese standard for respirator masks. Similar to the N95 standard in the U.S., masks must filter 95% or more of particles to meet the KN95 standard. However, a KN95 mask is NOT an N95 mask, nor approved by NIOSH. For more information about N95 masks, go to About KN95 masks.

In addition to N95 and KN95 masks, the following masks are also covered by this policy: N99, N100, R95, P95, P99, P100 masks, Surgical N95 masks, FFP2 and FFP3.

Our policy for particulate-filtering facepiece respirators

Amazon requires that all PFFRs covered by this policy must be tested and comply with the specific regulations or standard requirements listed below:

Models	Regulation/Standard requirements
N95, N99, N100, R95, P95, P99, P100	42 CFR Part 84 (Approval of Respiratory Protective Devices)
Surgical N95 masks	All of the following: FDA 510(k) Premarket Notification and 21 CFR Part 807 (FDA Establishment Registration) and 42 CFR Part 84 (Approval of Respiratory Protective Devices)
KN95 masks	One of the following: GB 2626-2006 or GB2626-2019
FFP2 and FFP3	EN 149-2001

Required information

We require the following information when you list a PFFR in our store:

Your contact information: physical address, email address and phone number
All particulate-filtering facepiece respirators that you list
Images for all particulate-filtering facepiece respirators that you list:
- all six-sides of the product packaging
- all respirators showing model number and compliance markings
Evidence confirming that your product was approved by NIOSH, if applicable.
For N95 Surgical provide the FDA 510K information
For KN95s masks only, in addition to the information above:
- Testing reports from a China National Accreditation Service for Conformity Assessment (“CNAS”)-accredited laboratory that confirm that each product was tested to the regulations and standards listed above
- Disclaimer on the product detail page that states: “Disclaimer: This KN95 mask is not an N95 mask. For more information about KN95 masks, go to About KN95 masks before you purchase.”

Note: Test reports must contain images of the tested products that are sufficient to demonstrate that the product tested is the same as the product listed 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, your listing privileges, or both
Withhold any payments due to you

We reserve the right to take any further actions that may be necessary in our sole discretion.

Additional resources

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.

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