Devices

FDA Grants, Denies Parts of Examination Glove Petition

FDA says it has granted a portion of a Public Citizen 5/2/11 petition asking that it ban the use of cornstarch powder on all surgeon’s and patient examination gloves. The agency also says it is denying a second request in the petition that it ban use of all natural rubber latex (NRL) surgeon’s and patient examination gloves.

The FDA response notes that it considered the petition as part of the basis for a proposed rule to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove that was finalized 12/19/16. Since that rule has been finalized, the letter says, the agency considers that it has granted the Public Citizen request.

Regarding NRL gloves, the letter says FDA finds that the risk of allergic reaction to non-powdered NRL gloves is adequately mitigated through already-required labeling that alerts users to the risk. The agency also notes that several studies have indicated that using non-powdered NRL gloves reduces the risk of sensitization to allergenic NRL proteins and the number of allergic reactions experienced by those who are already sensitized. “FDA believes that these study results, when considered alongside the risk mitigation that follows from FDA’s required labeling for NRL products, demonstrate that non-powdered latex gloves can be safely used with appropriate caution for latex-sensitive patients and healthcare workers,” the letter concludes. “Therefore, FDA has decided not to ban NRL products. For these reasons, we deny this part of your petition.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome