Saker Group

Saker Group brings new sources of medical-grade respirators and other personal protective equipment to the U.S. market by facilitating the FDA authorizations that are required before a foreign manufacturer's medical devices may enter the United States. If you are a U.S. buyer of medical protective equipment urgently seeking new, FDA-approved source... s of supply, contact us with your requirements. If you are a non-U.S. manufacturer of items in critical short supply, and can demonstrate the production and product standards required by the U.S. Food and Drug Administration, we can help you quickly obtain access to the U.S. healthcare market. Despite recent efforts to streamline and expedite regulatory approval following the February 4, 2020 declaration of a public health emergency, non-U.S. manufacturers must still obtain FDA authorization for each medical device, such as FDA-compliant respirator masks, before accessing U.S. healthcare buyers. As your U.S. agent, Saker Group will manage and expedite this approval process and serve as the registered U.S. importer for immediate access to the U.S. market.Read More