2/14/2011 - Written by the Medical Exam Glove team

On February 7, 2011, the Food and Drug Administration (FDA) issued a draft document reiterating the dangers of powdered exam gloves and powdered surgical gloves. The FDA is recommending the medical supplies industry to put warning statement labels on all powdered medical gloves. Since the original Medical Glove Powder Report issued on September 1997, the FDA has been discouraging healthcare workers from using medical gloves with powder by raising awareness of the potential dangers of developing irritant dermatitis. Research has shown that exposure to aerosolized powder that is found on powdered medical gloves can lead to respiratory problems. Since then, numerous independent researchers have drawn strong correlation of powder leading to health issues. The FDA is recommending all manufacturers to place warning statements on all powdered medical glove boxes to raise further awareness. This is for both latex surgical gloves and latex exam gloves that utilize powder.

In most cases, manufactures will use simple corn starch as the powdering agent for powdered latex gloves. Corn starch in itself does not pose the serious health hazard, but when combined with latex gloves it is another story. As the name suggests, latex gloves are made from natural latex which contain latex proteins that can cause sensitivity in individuals which can lead to contact dermatitis from frequent exposure. Latex proteins will bind with corn starch when both are mixed together. When powdered latex gloves are dispensed from exam glove boxes, powder residues are released into the air making healthcare workers and patients susceptible to breathing in the corn starch powdered agent with latex proteins. Breathing in latex proteins is worse than being exposed by the skin for individuals who are allergic to latex and the dangers are very serious. Risks include anaphylactic shock, acute asthma attacks, and even death. For this reason, it is generally recommended to avoid powdered medical gloves.

Today, technology has improved the quality of medical gloves rendering powdered latex exam gloves obsolete. Most new brands of exam gloves are now powder-free and manufactures have founds safer methods of making medical gloves easier to don and dispense. Since most glove manufacturers are pushing powder-free exam gloves, powdered versions are becoming more expensive than their powder-free counterparts.

On the plus, the overall market share for powdered medical gloves is declining, but there seems to be growing public skeptic on whether the FDA is doing enough. In 1998 Germany banned the use of powdered latex gloves and statistics showed a significant drop in latex allergy cases by nearly 80% within 5 years. Public Citizen, a consumer advocacy group, petitioned the FDA for a similar ban but the motion was rejected with reasons of not enough evidence linking powder to latex allergies. Now that this issue has been revisited, perhaps a more stringent warning is may be in order by placing a ban rather than just placing a label. A lot people have the mentality of if it’s not broken, don’t fix it. The concern from the consumer advocacy group is that the label will become overlooked similar to how cigarette warning labels are. From our side, all we can do is spread the warnings of powdered latex gloves. From a logical standpoint, there really is no reason to continue the use of powdered gloves. Powder-free latex gloves tend to be cheaper and same quality (if not better) than powdered versions.

Copy of FDA draft: Recommended Warning for ... Examination Gloves that Use Powder

References

Draft Guidance for Industry, Clinical Laboratories and FDA Staff Recommended Warning for Surgeon’s Gloves and Patient Examination Gloves that Use Powder. Food and Drug Administration. www.fda.gov.
Response to FDA regarding Powdered Medical Gloves. Public Citizen. www.citizen.org.

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