| Medical gloves provide a critical barrier in clinical | | | | respond to industry, consumer and regulatory needs. |
| environments, protecting both workers and patients. | | | | Otherwise, the guidelines are reviewed every five |
| In fact, the Center for Disease Control recommends | | | | years, and then re-approved or withdrawn. Each |
| that all healthcare workers wear gloves as a | | | | year, the ASTM publishes more than 10,000 |
| safeguard against HIV and other blood-and-fluid borne | | | | standards in a 70 plus volume set entitled Annual |
| infectious agents. | | | | Book of ASTM Standards. |
| To make sure medical gloves provide adequate | | | | ASTM Testing of Medical Gloves |
| protection, the Food and Drug Administration | | | | The ASTM requires different standards for different |
| enforces a variety of standards for glove | | | | medical gloves based on performance specifications. |
| manufacturers to follow when making and marketing | | | | Glove products are scientifically tested to accurately |
| gloves. | | | | assess products made from a variety of |
| The FDA's Authority over Medical Gloves | | | | manufacturing approaches, formulations and materials. |
| Initially, the FDA focused solely on regulating drugs. | | | | Rigorous analysis is conducted in a variety of areas, |
| But this changed with the May 28, 1976 introduction | | | | including the following: |
| of the Medical Device Amendments to the Federal | | | | 1. The Water Leak Test which consists of filling a |
| Food, Drug, and Cosmetic (FFD&C) Act. Now | | | | medical glove with 1,000 ml of water, suspending it |
| FDA regulations provide for the safety, | | | | for two minutes and then inspecting it for any |
| effectiveness, and proper use of all medical | | | | leakage; |
| devices--including disposable medical gloves. | | | | 2. The Air Inflation Test which involves inflating the |
| The FDA doesn't actually write standards for medical | | | | exam glove with compressed air and visually |
| devices. Instead, it recognizes guidelines written by | | | | inspecting it for holes; |
| others, such as the American Society of Testing and | | | | 3. The Chemical Permeation Test which measures the |
| Materials (ASTM), the American Association of | | | | resistance of protective clothing materials to |
| Medical Instrumentation (AAMI) and United States | | | | permeation by liquid or gaseous chemicals under |
| Pharmacopoeia (USP). FDA representatives do, | | | | conditions of continuous contact; |
| however, participate in standard-writing committees. | | | | 4. The Tensile Strength Test which measures the |
| Often, the FDA applies the established standards as | | | | amount of force in pounds per square inch that is |
| baseline requirements when evaluating medical | | | | needed to stretch a medical glove to the breaking |
| devices and supplies for the marketplace. As an | | | | point; |
| example, the FDA requires all medical glove | | | | 5. The V-Tear Test which determines the force |
| manufacturers to meet ASTM guideline D 5151 for | | | | required to initiate a tear in the medical glove; |
| the detection of holes in disposable exam gloves. | | | | 6. The Trouser Tear Test which measures the force |
| Medical Gloves and the ASTM | | | | needed to continue tearing once an initial tear has |
| ASTM is a nonprofit organization that provides a | | | | been made in the glove; |
| common ground for consumers, manufacturers, | | | | 7. The Puncture Resistance Test which determines |
| organizations, government representatives, and | | | | the glove material's ability to resist rupturing when |
| academia, to meet and write standards for variety | | | | stricken by an object and; |
| of products, services, and materials. Its guidelines are | | | | 8. Skin irritation and sensitization tests which |
| wholly recognized by the FDA. As a result, glove | | | | demonstrate the medical glove's potential for irritating |
| manufacturers must conform to these standards to | | | | the user's skin and possibly causing allergic contact |
| meet FDA requirements for the particular types of | | | | dermatitis. |
| medical gloves they market. Medical gloves, in fact, | | | | Most of these types of tests have specific |
| were some of the first products for which the | | | | Acceptable Quality Level (AQL) standards which the |
| ASTM developed standards. | | | | medical gloves must meet in order to pass FDA |
| Periodically, the ASTM revises its standards to | | | | regulations. |