Medical gloves provide a critical barrier in clinical environments, protecting both workers and patients. In fact, the Center for Disease Control 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 enforces a variety of standards for glove manufacturers to follow when making and marketing gloves.

The FDAs 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 devicesincluding disposable medical gloves.

The FDA doesnt 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 Otherwise, the guidelines are reviewed every five years, and then re-approved or withdrawn.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.

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 materials ability to resist rupturing when stricken by an object and;

8. Skin irritation and sensitization tests which demonstrate the medical gloves potential for irritating the users 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.