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Rep. Cooper's 510(k)s

This article was originally published in The Gray Sheet

Executive Summary

Rep. Jim Cooper (D-Tenn.) is listed as the contact person for two 510(k) submissions for powder-free latex exam gloves cleared by FDA on June 6 and contained in FDA's list of June 510(k) clearances. Hartalega SDN BHD sponsored the 510(k)s. Cooper staffers say the Congressman has no financial interest in the firm and that his name appears on the list because his office probably sent FDA a cover letter on behalf of a constituent asking the agency to review the products
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