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Article Title:
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Relief For Latex Allergy Sufferers As FDA Clears New Medical Glove

Article Description:
====================

Most allergies are easy to cope with by simply avoiding the
trigger. Sometimes that's easier said than done, such as in the
case of a latex allergy. Estimates vary, but anywhere from 3
percent to 22 percent of all health care workers are sensitized
to traditional latex. FDA recently cleared for marketing the
first device made from a new form of natural rubber latex called
guayule latex.


Additional Article Information:
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460 Words; formatted to 65 Characters per Line
Distribution Date and Time: 2008-07-29 11:00:00

Written By: Norm Howe
Copyright: 2008
Contact Email: mailto:info@...



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Relief For Latex Allergy Sufferers As FDA Clears New Medical Glove
Copyright (c) 2008 Norm Howe
Validation and Compliance Institute
http://www.vcillc.com



Most allergies are easy to cope with by simply avoiding the
trigger. Sometimes that?s easier said than done, such as in the
case of a latex allergy. Estimates vary, but anywhere from 3
percent to 22 percent of all health care workers are sensitized
to traditional latex.

For those in the healthcare profession, as well as patients who
suffer from a latex allergy, every day there are materials that
must be handled or avoided with caution, or suffer the
consequences, ranging from a mild rash, to, worst-case scenario,
anaphylactic shock.

Traditional latex gloves are made from the milky sap of a rubber
tree, Hevea braziliensis. That sap contains a protein that can
trigger allergic reactions, particularly after prolonged and
repeated contact. Allergic reactions run the gamut from skin
redness, rash, hives, or itching, to respiratory symptoms such as
difficulty breathing, coughing spells and wheezing, and, rarely,
shock.

Health care workers first began using traditional latex gloves in
the 1890s. The HIV epidemic of the 80s ushered in modifications
in glove materials, which made them more sensitizing to those
with latex allergies.

Some health care institutions responded by shifting to
alternative glove materials for their workers. The U.S. Food and
Drug Administration (FDA) also implemented numerous steps to
address the glove allergy problem, including working with the
industry to develop a consensus standard that identifies maximum
protein and powder levels for medical gloves. In addition, a 1998
rule requires that all medical devices containing latex carry a
statement on the label warning about the risk of allergic
reactions.

Most recently, FDA cleared for marketing the first device made
from a new form of natural rubber latex called guayule latex. The
product, the Yulex Patient Examination Glove, is derived from the
guayule bush, a desert plant native to the Southwestern United
States. The new material provides flexibility and strength
comparable to latex.

Available data on the new guayule latex show that even people who
are highly allergic to traditional latex do not react on first
exposure to guayule latex proteins. Because there is no data on
people?s long-term experience with the Yulex glove, which is made
by the Yulex Corporation of Maricopa, Ariz., the product will
carry a warning (for now) about the potential for allergic
reactions.

Products such as the Yulex glove, which utilize new materials in
inventive ways, are a benefit to both healthcare workers and
patients. To get the FDA stamp of approval, companies such as VCI
LLC can help. VCI specializes in compliance services that meet
FDA standards, as well as expertise in validation, production,
quality, and R&D. VCI also offers manufacturers a proactive
approach to getting it right the first time--before a product
even hits the shelf--thus negating the need for a reactive
response down the road.




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Norm Howe, Senior Partner at Validation and Compliance Institute,
consultants for the pharmaceutical and medical device industries.
He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA.
He has held many management positions in FDA regulated industries,
most at BASF. http://www.vcillc.com


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