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 that 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. Male condoms can be made of natural rubber or synthetic materials.
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. Female condoms can be made of natural rubber or synthetic materials.
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:
|Male and female condoms
21 CFR Part 807 (FDA Establishment Registration and Device Listing); and
21 CFR 807 Subpart E (FDA 510(k) Premarket Notification); and
21 CFR Part 801 (Medical Device Labeling)
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
Images of the product and product packaging, as applicable, for all male and female condoms that you list. Images must include all sides of the product and product packaging for our review
Product images must demonstrate compliance with FDA Labeling Requirement (21 CFR Part 801)
Product images and detail page content must comply with Amazon’s labeling for medical devices. For more information on this specific policy and our requirements, go to Amazon’s policy on medical devices and accessories
Documentation demonstrating all of the following:
Screenshots from FDA Listing Portal (FURLS) as evidence of compliance with FDA Establishment Registration Requirements (21 CFR Part 807)
Screenshots from FDA Listing Portal (FURLS) as evidence of compliance with FDA Device Listing Requirements (21 CFR Part 807)
FDA Approval Letter as evidence of compliance with FDA 510(k) Premarket Notification (21 CFR Part 807 Subpart E)
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 you receive a request from us for compliance documents, complete the
following steps to submit the requested information:
In Seller Central, select the Performance tab and choose
Under Manage your compliance in the bottom right corner, click
Product Compliance Requests.
To add compliance or appeal for a single product, click Add/Appeal
Compliance. To add compliance or appeal for multiple products, select each
product on the left hand side of the product and click Action Selected
Products at the top of the product requirement table to make a selection
about how you would like to submit documents and information.
Provide compliance documents and information in the Provide
Documents section, or provide appeal information and documents in the
Appeal Request section.
Click Submit for Approval to send your submission for review by
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.
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.
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.