How Disposable Medical Glove Standards Are Developed

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Article Title:

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How Disposable Medical Glove Standards Are Developed

Article Description:

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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:

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Distribution Date and Time: 2006-06-07 10:00:00

Written By: Irene

Copyright: 2006

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How Disposable Medical Glove Standards Are Developed

Copyright © 2006 Irene

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 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/