Citizen's Petition to Food and Drug Administration to ban cornstarch powder on medical gloves: Maltese cross birefringence

Developing an Organized Approach in the Food and Drug Administration to Ban Dangerous Devices that Can Injure the Patient and Health Care Worker

“…During the past 15 years, the Food and Drug Administration (FDA) and other federal agencies received numerous requests to ban the use of glove powder (1). It has been suggested that numerous experimental and clinical studies document that powder on medical gloves can enhance foreign body reactions, increase infection, cause peritoneal adhesions that cause intestinal obstruction, and act as a carrier of natural latex allergen that has lead to a latex allergy epidemic in our country.…”

Center for Devices and Radiologic Health Agrees to Have a Healthcare Comment Site in the Federal Register Regarding Banning Cornstarch Powder on Medical Gloves

“…1 2 Realizing the documented dangers of cornstarch powder discussed in detail in the referenced petitions, many glove manufacturers have introduced an ample supply of high-quality, customer-preferred, powderfree natural rubber latex (NRL) and synthetic gloves since 1998. 3 Today, more than 90% of examination gloves and more than 60% of surgical gloves used in hospitals are powderfree. Medical glove manufacturers have increased the availability and manufacturing capacity of powder-free gloves significantly since 1998.…”

“…In addition, the average price of powder-free surgical gloves has declined by as much as 44%. 1 During the 2-year review process, Edlich and his colleagues had conference calls with Paul Gadiock of Regulatory Affairs of the FDA. One of the major topics of their discussions was to find one scientific article that documented that cornstarch on medical gloves was safe.…”

Discontinuing the Use of Dangerous Cornstarch Powder on Medical Gloves

“…An extensive survey of the second quarter 2008 market research data of gloves used in the United States by GHX Market Intelligence in Louisville, CO, showed the following for total examination glove market (physician offices, surgery centers, and hospitals) 10 : powder-free examination gloves (units) 94.4%; and powdered examination gloves (units) 5.6%. The second quarter 2008 market research data showed the following for total surgical glove market: powder-free surgical gloves (units), 64.4%; and powdered surgical gloves (units), 35.4%.…”

“…8,9 Realizing the documented dangers of cornstarch powder listed earlier, on September 24, 2008, 11 health care professionals submitted a Citizen's Petition to the Food and Drug Administration (FDA) to ban immediately the use of cornstarch powder in the manufacture of surgical and examination gloves. 10 Because of the dangers of this dangerous powder on medical gloves, since 1998, many manufacturers have introduced a large supply of powder-free, high-quality, inexpensive, easily donned, natural rubber latex, and synthetic gloves.…”