Policies and Regulations
“Of gloves made from other materials, such as synthetic rubbers or polymers, "none possesses the unique mix of properties found in NRL [natural rubber latex] gloves."
-Medical Glove Powder Report, U.S. Food and Drug Administration
|Regulatory Requirements for Medical Gloves by the U.S. Food and Drug Administration (FDA)
Medical devices are some of the many items/products regulated by the FDA, a scientific, regulatory and public health agency that oversees about 25% of gross national products in the United States.
All medical gloves marketed in the U.S. are required by the FDA to be correctly labeled and cleared for marketing through a premarket notification submission [510(k)] prior to being distributed in the country. The FDA also requires manufacturers to produce gloves according to the Quality System (QS) regulation (known as Good Manufacturing Practices regulation earlier) to assure that gloves are produced at an acceptable quality level, thereby helping to assure their safety and effectiveness. The FDA believes that gloves worn by health care workers must provide an effective barrier to the transmission of infectious agents.
Medical gloves are classified by the FDA into one of three regulatory Classes: I, II and III as required by the Food Drug and Cosmetic Act. The class of a device determines the level of regulatory control that applies to it. Medical gloves are in Class I, but the FDA has proposed in 1999 that surgeon's gloves and patient examination gloves be reclassified into Class II, because it is thought the general controls in Class I are not sufficient to assure the glove safety and effectiveness. However, this proposal has not yet been finalized today.
Under the FDA regulations, medical gloves are subject to the following general controls:
|Latex Gloves and Health Safety
Barrier of Choice in the U.S.
CDC : Glove use reduces infection rates
The Center for Disease Control and Prevention (CDC) recommends hand hygiene practices and glove use to prevent outbreaks in health care facilities, minimize transmission of antimicrobial resistant organisms, and reduce overall infection rates.
The following were selected statements from the US Food and Drug Administration (FDA) report entitled Medical Glove Powder Report, updated on 30 April 2009.
|NIOSH & OSHA: Latex gloves aid barrier protection
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