Amazon has made changes on Seller Central, this time to their policies for medical gloves sold on their marketplace. Sellers on Amazon are being alerted to new forms of documentation in order to post their medical gloves on Amazon’s site.

The new policy changes are an effort to keep sellers compliant with current FDA regulations for medical devices, which includes medical gloves. The regulations that Amazon is concerned with are 21 CFR 807 (FDA Establishment Registration and Listing), 21 CFR 807 subpart E (FDA 510(k) premarket notification), and 21 CFR 801 (Medical Device Labeling). As evidence of compliance with these rules, Amazon is requiring the following documentation:

• Product images of every side of the packaging
• Screenshot of the Establishment registration number
• Copy of the 510(k) approval letter
• Test report from an ISO 17025 Lab confirming that the label meets 21 CFR 801 for medical device labeling.

Complying with the last Amazon requirement may prove difficult because many laboratories do not currently review labels for compliance with 21 CFR 801, as Amazon is requesting.

Amazon Dietary Supplement Policy – https://sellercentral.amazon.com/gp/help/external/WU7WD8984FT4YLJ

If you have any questions about Amazon’s updated requirements, please contact us.