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Policies & Regulations Early Strategies in Addressing Latex Allergy Concerns Developments in Addressing Allergy Concerns Food Safety

POLICIES & 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
Updated 30 April 2009

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 productsin the United States.

All medical gloves marketedin 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:

Establishment Registration
Device Listing
Premarket Notification or 510(k) submission
Device Labeling
Quality System requirements (QS)
Medical Device Reporting (MDR)

All domestic and foreign medical glove manufacturers, distributors, repackers and other related agencies who wish to market their gloves in the United States are required to register, and list their products. The Premarket Notification (510k) includes a summary of information regarding the device, such as its "indication for use", its technological characteristics with measured parameters compared to ASTM (American Society for Testing and Materials) or equivalent standards; data showing compliance with FDA biocompatibility, pinhole, powder-free and other requirements and recommendations, as well as any labeling claims, for example: protein label claim and chemotherapy label claim. Clinical data is not needed for gloves cleared by the 510(k) process.

For further information on general controls and compliance, please refer to: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/

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 CDC states that "gloves reduce hand contamination by 70 percent to 80 percent, prevent cross-contamination and protect patients and health care personnel from infection."

FDA: NRL glove is the barrier of choice

The following were selected statements from the US Food and Drug Administration (FDA) report entitled Medical Glove Powder Report, updated on 30 April 2009.

Natural rubber latex gloves are the barrier of choice in the U.S.
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." These include high elasticity and tensile strength, and excellent film-forming characteristics.
NRL is pliable, allowing for natural molding for more appropriate fit and has the ability to reseal when tiny punctures occur.
In general, NRL provides comfort to the wearer, adequately protects against microorganisms, and provides adequate barrier effectiveness when used for medical and nursing procedures."

NIOSH & OSHA: Latex gloves aid barrier protection

Federal health agencies such as the National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) recommend the use of appropriate barrier protection, including the use of low-protein latex gloves, when handling infectious materials, (OSHA 2008).

Early Strategies in Addressing Latex Allergy Concerns

Food and Drug Administration (FDA)

The FDA has assumed a leading role in regulating the marketing and use of medical gloves. At the onset of the latex protein allergy problem in the 1990s, the FDA took the following measures:

Instituted requirements in 1993 for all shipments of medical gloves into the U.S. to be inspected, and if found to be deficient in terms of holes, color, mold or lacking in 510(k) and other detailed information, detention would be imposed. After a third detention, glove shipments from the affected manufacturing companies would be disallowed altogether until the FDA is satisfied that the necessary remedial actions to improve factory operations are in place.
Published the Medical Glove Powder Report in 1997, which examined the role of powder in gloves and as a carrier of latex allergenic proteins. This was done to address confusion involving glove powder and latex allergy.
Required warning labels on all medical devices containing natural rubber. Since September 1998, labeling of medical gloves must include the statement: "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
Published a new proposed rule for all medical devices in 1999, (which has never been finalized), whereby medical gloves would be reclassified from Class I devices to Class II, which would require the devices to comply with more stringent specifications. In addition, latex gloves would need to meet certain protein and powder upper limits, while expiration dating would also be included.
Although an option mentioned in the Medical Glove Powder Report (1997) was to "ban powdered medical gloves at some predetermined time in the future," the FDA rejected an outright ban on powdered natural rubber latex gloves. In its Medical Glove Powder Report (1997), the FDA emphasized the unique properties possessed by powdered natural rubber latex medical gloves. For example, it said, powdered latex gloves possess superior barrier protection, which lasts long after donning; have unmatched ability to stretch and conform to the shape of the hand without tearing; and offer the tactile sensitivity necessary to perform delicate medical procedures. Powdered latex gloves are also affordable at a time when healthcare providers seek to keep costs down.

National Institution for Occupational Safety and Health (NIOSH)

In 1997, NIOSH developed a safety Alert entitled, "Preventing Allergic Reactions to Natural Rubber Latex in the Workplace." The Alert recommended the use of reduced protein content powder-free gloves when latex gloves were used for effective barrier protection against infections and minimum exposure to latex proteins at work places.

Occupational Safety & Health Administration (OSHA)

OSHA, under the U.S. Department of Labor, was involved in setting guidelines for health care workers through a Technical Information Bulletin on April 12, 1999, entitled, "Potential for Allergy to Natural Rubber Latex Gloves and other Natural Rubber Products."

Developments in Addressing Allergy Concerns

Today's Developments in Addressing Latex Allergy Concerns

It is now apparent that the cause of latex protein sensitization and allergic reactions of sensitive individuals is attributed to the use of an older generation of latex gloves with no control their protein and powder levels. Advancements in latex glove manufacturing technologies have now led to the production of low-protein, lightly powdered or powder-free latex gloves. The use of these gloves has in fact been shown by a number of recent independent hospital studies to vastly reduce the incidence of latex sensitization and reactions in workplaces. The studies also showed that latex allergic individuals donning synthetic gloves can work alongside co-workers wearing latex gloves without having allergic reactions. To review these studies, go to Hospital Studies

The advent of these improved low-protein/allergen gloves enables the majority of healthcare professionals who are not latex allergic to continue to rely on the superior barrier protection that latex gloves provide. This is not withstanding the fact that latex gloves are also known to offer excellent comfort, fit, tactile sensitivity, and durability - critical glove characteristics that manufacturers of many synthetic gloves are attempting to achieve.

However, in the absence of any regulatory requirements by the FDA limiting glove protein levels, latex gloves with high protein and powder content are still available in the marketplace. Precautions must be taken by healthcare personnel to select the right latex gloves - those that are high-quality, low-protein and lightly powdered or powder-free.

As the FDA is still deciding whether or not to finalize its 1999 proposed rule for medical devices, OSHA is in the process of revising its 1999 guidelines in the Technical Information Bulletin.

CPSC Denies Petition Declaring Natural Rubber Latex a Strong Sensitizer

On December 10, 2003, the Consumer Product Safety Commission held a hearing on a petition to declare natural rubber latex a strong sensitizer and to require latex products to be labeled as such. The Commission concluded that "the information currently available is not sufficient to begin a rulemaking proceeding to declare NRL a strong sensitizer." Click here to view a copy of the denial letter and statement issued by CPSC Commissioner Thomas H. Moore filed June 4, 2004.

Food Safety

CFSAN and FDA Examined Latex Allergy Concerns in Relation to Food Safety

Questions have been raised about whether the use of latex gloves in food handling can cause allergies. There is little scientific evidence to support that view.
Go to Food Safety for more information.

Insufficient scientific evidence to link latex food gloves and allergies

The Additives and Ingredients Subcommittee of the Food Advisory Committee of the U.S. Food and Drug Administration concluded that there is insufficient scientific evidence to establish that latex allergy could be elicited by food ingestion through the use of latex gloves in food handling.
A report presented at the Food Protection Conference in Nashville, TN, in April 2002 indicated that self-reported cases of food-mediated allergies received from consumers were "not clinically verified through medical records" and that "it is possible that some of the reactions described could have been due to the consumption of foods that cross react to latex protein (e.g., kiwi, bananas, buckwheat, stone fruits, potatoes, tomatoes, sweet pepper, chestnuts, spinach etc.)."