Federal Agencies

The U.S. Food and Drug Administration (FDA): <www.fda.gov>

Center for Devices and Radiological Health (CDRH): <www.fda.gov/cdrh/


In September 1997, the FDA issued its "Medical Glove Powder Report." Nine recommendations were made, including: 1) Establish a maximum allowable powder level for powdered gloves; 2) Standardize the maximum allowable amount of powder on powder-free gloves; 3) Establish a maximum allowable glove protein level; and 4) Require labeling on all medical gloves of glove powder content and water-soluble protein.

Effective September 30, 1998, the FDA requires that all medical devices containing latex carry a warning for those allergic. The rule also prohibits the use of the claim "hypoallergenic" on labels of products that contain latex.

The National Institute for Occupational Safety and Health (NIOSH): <www.cdc.gov/niosh/homepage.html>

NIOSH issued an alert, "Preventing Allergic Reactions to Natural Rubber Latex in the Workplace," in June 1997. (DHHS Publication No. 97-135).61 In this, they listed a series of recommendations for employers and workers to minimize exposure to latex. Prominent among these are: 1) Use of non-latex products whenever possible; and 2) When latex gloves are used, they should be powder-free.

The Centers for Disease Control and Prevention (CDC): <www.cdc.gov>

The CDC is updating its guidelines for infection control in health care personnel. They describe several strategies for health care workers with "Latex Hypersensitivity," including: 1) Develop an institutional protocol for managing personnel with latex allergy; 2) Provide workers with a non-latex or low-allergen powderless latex gloves; and 3) Consider targeted substitution of non-latex gloves and/or powder-free latex gloves.

The Occupational Safety and Health Administration (OSHA): <www.osha-slc.gov/SLTC/LatexAllergy/index.html>

OSHA Standard 29 CFR 1910.1030 contains a requirement that an employer must provide "hypoallergenic gloves, glove liners, powderless gloves or other similar alternatives" to employees who are allergic to latex gloves.

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