Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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



Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts