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This article applies to selling in: United States

Male and female condoms

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.

Male condoms covered by this policy

A male condom is a sheath which completely covers the penis with a closely fitting membrane. A male condom is used for contraceptive and prophylactic purposes, and may prevent the transmission of sexually transmitted infections and diseases. The device may also be used to collect semen to aid in the diagnosis of infertility. Male condoms can be made of natural rubber or synthetic materials.

Examples of male condoms


Female condoms covered by this policy

A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of intercourse. A female condom is used for contraceptive and prophylactic purposes, and may prevent the transmission of sexually transmitted infections and diseases.

Examples of female condoms


Our policy for male and female condoms

Amazon requires that all male and female condoms have been tested to and comply with the specific regulatory requirements listed below:

Product Regulation/Standard requirements
Male and female condoms
  • 21 CFR Part 807 (FDA Establishment Registration andDevice Listing); and
  • 21 CFR 807 Subpart E (FDA 510(k) Premarket Notification); and
  • 21 CFR Part 801 (Medical Device Labeling)

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 male and female condoms that you list
  • Product packaging and label images for all male and female condoms that you list
    • Product images must show all sides of the product packaging
    • Product images and detail page content must comply with Amazon’s labeling policy for medical devices. For more information on this specific policy and our requirements, visit Amazon’s policy on medical devices and accessories
  • Documentation demonstrating all of the following:
    • FDA Establishment Registration number (21 CFR Part 807) - Screenshot
    • FDA Device Listing (21 CFR 807) – Screenshot
    • FDA 510(k) Premarket Notification (21 CFR 807 Subpart E) – FDA Approval Letter
  • Test reports from an ISO 17025 accredited lab confirming that each product meets Medical Device Labeling requirements (21 CFR Part 801)

Some labs provide special Amazon rates for testing. To find more information about these providers, visit 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, and warning labels if applicable. The product images on the test reports must show the same product as 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, 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

Disclaimer

The information provided on this page, and anywhere else on this website, does not, and is not intended to, constitute legal advice; instead, all information, content, and materials available on this site are for general informational purposes only.

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