Dr. Richard F. Edlich - Comment
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This is a Comment on the Food and Drug Administration (FDA) Other: Richard F. Edlich, M.D., Ph.D., (University of Virginia Health System) - Citizen Petition
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Comment
When Mr. Gadiock and I have searched for one article that confirms the safety of cornstarch coated gloves, we have not identified one article. Because there are hundreds of articles that confirms the dangers of cornstarch on medical gloves, the device classification of cornstarch coated gloves should be class III because cornstarch coated surgical and examination gloves cannot be safely used without either injuring the patient or the healthcare worker. Like the United Kingdom and Germany, powdered gloves are not allowed in the healthcare system. There is an ample supply of inexpensive powder free surgical and examination gloves that have superb levels of performance and can be safely used in the healthcare system without endangering either the patient or the healthcare worker.
Dr. Richard Edlich richardedlich@gmail.com
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Comment Period Closed
ID:
FDA-2010-P-0352-0039
Tracking Number:
80b3f4ec
Submitter Information
Country:
United States
Category:
Health Professional - A0007
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