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Article Title:
==============

How Disposable Medical Glove Standards Are Developed

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

Medical gloves provide a critical barrier in clinical
environments, protecting both workers and patients. In fact,
the CDC recommends that all healthcare workers wear gloves as a
safeguard against HIV and other blood-and-fluid borne infectious
agents. To make sure medical gloves provide adequate protection,
the FDA enforces a variety of standards for glove manufacturers
to follow when making and marketing gloves.


Additional Article Information:
===============================

610 Words; formatted to 65 Characters per Line
Distribution Date and Time: 2006-06-07 10:00:00

Written By: Irene Perez
Copyright: 2006
Contact Email: mailto:jkeller@...

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How Disposable Medical Glove Standards Are Developed
Copyright © 2006 Irene Perez
Don The Glove Nitrile Gloves
http://www.dontheglove.com



Medical gloves provide a critical barrier in clinical
environments, protecting both workers and patients. In fact, the
Center for Disease Control ( http://www.cdc.gov/ ) recommends
that all healthcare workers wear gloves as a safeguard against
HIV and other blood-and-fluid borne infectious agents.

To make sure medical gloves provide adequate protection, the Food
and Drug Administration ( http://www.fda.gov/ ) enforces a
variety of standards for glove manufacturers to follow when
making and marketing gloves.


The FDA's Authority over Medical Gloves

Initially, the FDA focused solely on regulating drugs. But this
changed with the May 28, 1976 introduction of the Medical Device
Amendments to the Federal Food, Drug, and Cosmetic (FFD&C) Act.
Now FDA regulations provide for the safety, effectiveness, and
proper use of all medical devices-including disposable medical
gloves.

The FDA doesn't actually write standards for medical devices.
Instead, it recognizes guidelines written by others, such as the
American Society of Testing and Materials (ASTM), the American
Association of Medical Instrumentation (AAMI) and United States
Pharmacopoeia (USP). FDA representatives do, however, participate
in standard-writing committees.

Often, the FDA applies the established standards as baseline
requirements when evaluating medical devices and supplies for the
marketplace. As an example, the FDA requires all medical glove
manufacturers to meet ASTM guideline D 5151 for the detection of
holes in disposable exam gloves.


Medical Gloves and the ASTM

ASTM is a nonprofit organization that provides a common ground
for consumers, manufacturers, organizations, government
representatives, and academia, to meet and write standards for
variety of products, services, and materials. Its guidelines are
wholly recognized by the FDA. As a result, glove manufacturers
must conform to these standards to meet FDA requirements for the
particular types of medical gloves they market. Medical gloves,
in fact, were some of the first products for which the ASTM
developed standards.

Periodically, the ASTM revises its standards to respond to
industry, consumer and regulatory needs. Otherwise, the
guidelines are reviewed every five years, and then re-approved or
withdrawn. Each year, the ASTM publishes more than 10,000
standards in a 70 plus volume set entitled Annual Book of ASTM
Standards ( http://www.astm.org/BOOKSTORE/BOS/ ).


ASTM Testing of Medical Gloves

The ASTM requires different standards for different medical
gloves based on performance specifications. Glove products are
scientifically tested to accurately assess products made from a
variety of manufacturing approaches, formulations and materials.
Rigorous analysis is conducted in a variety of areas, including
the following:

1. The Water Leak Test which consists of filling a medical glove
with 1,000 ml of water, suspending it for two minutes and then
inspecting it for any leakage;

2. The Air Inflation Test which involves inflating the exam glove
with compressed air and visually inspecting it for holes;

3. The Chemical Permeation Test which measures the resistance of
protective clothing materials to permeation by liquid or gaseous
chemicals under conditions of continuous contact;

4. The Tensile Strength Test which measures the amount of force
in pounds per square inch that is needed to stretch a medical
glove to the breaking point;

5. The V-Tear Test which determines the force required to
initiate a tear in the medical glove;

6. The Trouser Tear Test which measures the force needed to
continue tearing once an initial tear has been made in the
glove;

7. The Puncture Resistance Test which determines the glove
material's ability to resist rupturing when stricken by an
object and;

8. Skin irritation and sensitization tests which demonstrate the
medical glove's potential for irritating the user's skin and
possibly causing allergic contact dermatitis.


Most of these types of tests have specific Acceptable Quality
Level (AQL) standards which the medical gloves must meet in order
to pass FDA regulations.





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Irene Perez is General Manager of DonTheGlove.com, the online
division of Handgards Inc, a 45 year old company specializing
in hand protection products. Irene is the company's expert
in medical gloves and a frequent contributor to the website's
resource centers. If you thought this article was helpful,
explore additional articles now at: http://www.dontheglove.com/


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