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This article applies to selling in: United States

COVID-19 Supplies

This page covers product sold on the COVID-19 Supplies storefront. For more information on COVID-19 Supplies and how you can request approval to sell these products, visit: http://www.amazon.com/COVID-19-Supplies.

COVID-19 Supplies is limited to pre-approved sellers. If you are approved to sell in COVID-19 Supplies, you may only sell the specific ASINs for which you have been approved to sell. If you would like to sell additional products in COVID-19 Supplies, or add an offer to an ASIN that is already part of COVID-19 Supplies, you must obtain prior approval.

These products are being made available exclusively to customers in need of these supplies, including hospitals, government organizations, and others on the front lines of COVID-19. As such, it is critical that all product information is accurate. In addition to our Restricted Products policies, these products must comply with the guidelines below, unless you have received an express exemption from Amazon.

General guidance

Medical devices must meet the applicable requirements found under the Medical devices and accessories policy, including:

  1. The manufacturer’s name and the product’s country of origin should be included prominently on the detail page in the key product features/bullet points.
  2. Medical devices must not make false or misleading statements. Misleading statements include any claims that the product protects against viruses or COVID-19 (with the only exception of specific sanitizers mentioned below).
  3. Medical devices must use the claims "FDA Cleared" or "FDA approved" appropriately (for more information, see Is It Really ‘FDA Approved?’). Masks, gowns, and other medical devices cannot claim to be approved by the FDA.
  4. Medical devices must not use the FDA logo (for more information, see Is It Really ‘FDA Approved?’).

CE Marking

CE marking is a certification that a product meets applicable European Union standards. CE markings are not required for products sold in the US COVID-19 Supplies store, but if you sell a product that includes a CE marking, then it must meet all EU requirements for displaying the CE mark. See this website for more information on CE markings and the requirements for displaying them on your products.

Masks and respirators

N95 masks

  1. N95 masks must be listed on NIOSH’s list of approved respirators and may include "NIOSH Approved" or "NIOSH Certified" on the detail page.
  2. N95 masks cannot make any "medical" or "surgical" claims on the detail page or product packaging, unless they separately meet the requirements listed below for surgical masks.

Equivalents of N95 masks (for example, KN95)

  1. These masks must either meet the performance standard of a jurisdiction covered by the FDA’s Emergency Use Authorization (see Stakeholders for Non-NIOSH-Approved Imported FFRs) or appear in the FDA’s list of Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China.
    1. KN95 models that appear in the FDA’s list of Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China must include the following statement in the key product features/bullet points: “Included on the FDA Emergency Use Authorization List.”
    2. KN95 models that do not appear in the FDA’s list must have a testing report from an acceptable, independent lab demonstrating a minimum filtration of 95%, and they must include the following statement in the key product features/bullet points: “This product is not included on the FDA Emergency Use Authorization List, and the CDC has not confirmed its filtration efficiency.”
    3. If a KN95 mask fails testing by the CDC or another source, then Amazon may remove the listing, and you will be responsible for any concessions to customers and FBA removal fees.
    4. Additional information on the FDA’s list and how to apply to be included is available on the FDA’s website and the Emergency Use Authorization.
  2. KN95 masks and other international equivalents cannot make any "medical" or "surgical" claims on the detail page or product packaging unless they separately meet the requirements listed below. However, they should include the manufacturer's name on the detail page.

Surgical masks

  1. Any mask claiming to be a "surgical" mask must be manufactured by an FDA-registered manufacturer and have a 510(k) filed with the FDA pertaining to the specific product.
  2. Surgical masks may describe the applicable ASTM standard, but only if the claim has been substantiated.
  3. Additional recommended language for the key product features or bullet points: "These masks are class II medical devices, and are intended for use by operating room personnel during surgical procedures to protect both the patient and the medical personnel from transfer of microorganisms, bodily fluid, and particulate material."

Procedural mask

  1. These are class 1 medical devices that are exempt from the FDA’s 501(k) reporting requirements. These products must be manufactured by an FDA registered manufacturer.
  2. These masks may claim to be “medical” but they cannot claim to be “surgical”.
  3. Additional recommended language for key product features/bullet points: “These masks are class 1 medical devices, and can be used for healthcare use, but should not be used in surgical or high risk situations, or where there is a high risk of contact with liquids or infectious materials."

Other masks (face masks, dust masks)


  1. These are general purpose face masks that don’t meet the standards of other masks described above.
  2. These masks may not make any claims regarding medical or surgical use on the detail page or product packaging.
  3. Additional recommended language for key product features or bullet points: "This mask is not intended for medical use, and not proven to reduce the transmission of disease."

Disposable gloves


  1. Examination or medical: Any gloves making a medical claim (for example, appropriate for medical, hospital, etc.) must be manufactured by an FDA-registered manufacturer and have a 510(k) filed with the FDA pertaining to the specific product.
    1. Additional recommended language for key product features or bullet points: "These products are class 1 medical devices, and can be used for healthcare use, but should not be used in surgical or high-risk situations, or where there is a high risk of contact with liquids or infectious materials."
  2. Other disposable gloves: may be sold, but they cannot make any claims related to medical use (for example, examination, surgical, patient, etc.) on the detail page or product packaging.
    1. Include the following in the key product features or bullet points: "This product has not been approved by the FDA."
  3. All glove products should accurately describe their sterility status (that is, "sterile" or "non-sterile"), but only gloves that meet FDA’s sterilization requirements may claim to be "sterile".
  4. All gloves should list the material (for example, latex) from which they are made on the detail page.

Gowns, scrubs, aprons, and shoe covers


  1. All gowns, scrubs, aprons and shoe covers should disclose the materials from which the product is made.
  2. Surgical gowns and scrubs: Any gowns or scrubs described as "surgical" must be manufactured by an FDA-registered manufacturer and have a 510(k) filed with the FDA pertaining to the specific product.
  3. Isolation gowns: If the isolation gown makes any medical claim, then it must be manufactured by an FDA-registered manufacturer and have a 510(k) filed with the FDA pertaining to the specific product.
    1. Additional recommended language for key product features/bullet points: “These products are class 1 medical devices, and can be used for healthcare use, but should not be used in surgical or high-risk situations, or where there is a high risk of contact with liquids or infectious materials.”
  4. Other gowns and aprons; head covers and shoe covers: If the product makes any medical claim, then it must be manufactured by an FDA-registered manufacturer. Other types of gowns, aprons, head covers and shoe covers may be sold provided that they don’t make any medical claims on the detail page or product packaging.
    1. If the manufacturer is FDA-registered, we recommend including the following on the key product features/bullet points: “These products are class 1 medical devices, and can be used for healthcare use, but should not be used in surgical or high-risk situations, or where there is a high risk of contact with liquids or infectious materials.”
    2. If the manufacturer is not FDA-registered, include the following disclaimer in the key product features/bullet points: “This is a non-surgical product and should not be used in surgical or high-risk situations, where Level 3 or 4 protection is warranted, where there is a high risk of contact with liquids or infectious materials, or in the presence of a high-intensity heat source or flammable gas.”

Face shields and protective goggles


  1. If the face shield or goggles makes any medical claim, then it must be manufactured by an FDA-registered manufacturer. Other face shields and goggles may be sold provided that they don’t make any medical claims on the detail page or product packaging.
  2. If the manufacturer is FDA-registered, we recommend including the following on the key product features/bullet points: “These products are class 1 medical devices, and can be used for healthcare use, but should not be used in surgical or high-risk situations, or where there is a high risk of contact with liquids or infectious materials.”
  3. If the manufacturer is not FDA-registered, include the following disclaimer in the key product features/bullet points: “This product has not been approved by the FDA.”

Thermometers


  1. Digital thermometers, including infrared: Products must be manufactured by an FDA-registered manufacturer and have a 510(k) filed with the FDA pertaining to the specific product.
  2. Non-digital thermometers: Products must be manufactured by an FDA-registered manufacturer.

Disinfectants


  1. Products must be manufactured by an FDA-registered manufacturer. If the product is marketed for use in disinfecting medical devices, then it must also have a 510(k) filed with the FDA pertaining to the specific product.
  2. If the product makes a claim about killing coronavirus, it must meet the following:
    1. The product qualifies for emerging viral pathogen claims per the EPA's Guidance to Registrants: Process for Making Claims Against Emerging Viral Pathogens not on EPA-Registered Disinfectant Labels, or
    2. The product is listed in the EPA's List N: Disinfectants for Use Against SARS-CoV-2.

Hand sanitizers


  1. All products must include an image of the product label showing the active ingredient and concentration.
  2. For products that are registered under the FDA’s Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, products must be manufactured using only the ingredients specified in WHO formulas described in the guidance (80 percent ethyl alcohol or 75 percent isopropyl alcohol). They must also include labels that follow the exact wording in Appendix A, B, C, or D of the guidance as applicable.
  3. All other hand sanitizers must meet applicable FDA requirements, including FDA registration and OTC labeling requirements. The only permitted ingredients for these products are benzalkonium chloride, ethyl alcohol or Ethanol (60 to 95 percent), and isopropyl alcohol (70 to 91.3 percent).

Last updated May 15, 2020

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