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.
Medical gloves covered by this policy
Medical gloves are a type of personal protective equipment used to protect the wearer and patient from the spread of infection or illness during medical procedures and examinations. Medical gloves can be made of latex or non-latex materials such as vinyl or nitrile. Medical gloves are single-use, disposable products.
Examples of medical gloves
Our policy for medical gloves
Amazon requires that all medical gloves have been tested to and comply with the specific regulation or standard requirements listed below:
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 medical gloves that you list
Product packaging and label images for all medical gloves that you list
Product images must show all sides of the product packaging
Product images and detail page content must comply with FDA Labeling Requirement (21 CFR Part 801), as well as 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:
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
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.