FAQ - Latex Allergy

What are latex allergies?

Some individuals may experience allergic reactions when wearing or after wearing latex or plastic gloves. It has been known that products, other than gloves, which contain natural rubber latex, such as: balloons, balls, toys that contain rubber material; rubber bands, hoses, boots and rubber parts of instruments; tires, erasers, mouse pads, helmets, condoms, etc. may cause irritation or allergic reactions in some individuals. These reactions range from dry, itchy, crusty skin with cracks or sores, to a runny nose, wheezing, difficulty breathing, swelling in the face, cramps and shock. Rare cases can even be potentially life threatening.

As of this time, researchers are still unable to determine the exact level of latex protein, or the length of time an individual needs to be exposed to become allergic.

What do I need to know about Latex Protein Levels?

ASTM has set and the FDA has proposed a maximum of 200µg/g (µg/dm 2) for any glove. FDA has allowed a level of 50 µg/g (µg/dm 2) as a lower limit on claims using the Lowry test. The new ASTM ELISA test is hoped to be able to allow claims of 1/5th of that or less. While there are probably meaningful differences between 200, 50 and 10, users should be wary of attempting to make judgments on small differences in values in between these broad ranges.

For additional information visit http://www.lgm.gov.my/latex_allergy/lpa_link02.html

Are gloves that have "hypoallergenic" claim safe for everyone?

No. The FDA has ruled and required that the labeling of "hypoallergenic" be removed from all glove packaging effective on September 30, 1998. The FDA has received reports of allergic reactions to medical gloves labeled as "hypoallergenic".

The use of the "hypoallergenic" label had been based on the results of the modified Draize test, which may have been appropriate for detecting sensitization to residual levels of processing chemicals in a product. However, the test does not detect an individual’s sensitivity to natural latex protein.

The FDA believes that "hypoallergenic" labeling on devices that contain natural rubber latex is misleading, as it incorrectly implies that such devices may be used safely by individuals who are sensitive to natural latex protein.

Therefore, the FDA has required that hypoallergenic claims be removed from the labeling of all medical devices that contain natural rubber. For more information, please visit the FDA web site at: http://www.fda.gov


What can you do to help relieve or treat Irritant Contact Dermatitis or Type IV - Chemical Hypersensitivity?

There are several things you can do to help relieve these glove-related irritations or reactions:

 

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