Choosing the right type of medical gloves can be a daunting and confusing. But it doesn’t have to be, if you understand the standards and tests that are used to measure the performance of medical gloves. Knowing this can help you make an intelligent evaluation of different glove products. And this can help you determine which type of glove is the best for specific situations and procedures.

First, it’s important to understand that the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is responsible for regulating medical devices such as gloves. FDA requirements define performance properties, such as the minimum strength and barrier protection that these products must exhibit. Standards and test methods are developed by organizations such as the American Society of Testing and Materials and various international groups. Many of these members are This helps assure that the tests are scientifically sound and appropriate and that the test methods fairly and accurately assess products made from a variety of manufacturing approaches, formulations and materials. Testing is conducted in a variety of areas including barrier protection, strength, biocompatibility and protection against microorganisms.

Barrier Protection Confidence Tests in Medical Gloves
All medical gloves must meet certain Acceptable Quality Level (AQL) standards. This relates to the product’s freedom from pinholes and typically refers to the barrier protection confidence level. A lower AQL number represents a higher quality product. For the purpose of sampling inspection, the AQL is used by manufacturers to identify the maximum number of allowable defects (pinholes) per 100 units. Medical gloves inspected to an AQL of 2.5 must have fewer than 2.5 defects for every 100 gloves.

There are two tests used to verify AQL in gloves: the water leak test and the air inflation test. The Water Leak Test consists of filling a glove with 1,000 ml of water, suspending it for two minutes and then inspecting it for any leakage. Air Inflation Tests consists of inflating the glove with compressed air and visually inspecting it for holes. One additional test measures the medical gloves’ resistance to chemicals -- the Chemical Permeation Test. This measures the resistance of protective clothing materials to permeation by liquid or gaseous chemicals under conditions of continuous contact.

Strength Tests in Medical Gloves
Strength tests are done to simulate the stress medical gloves undergo during actual usage. Glove strength is measured by resistance to tearing, puncturing and breaking and by stretchability. Testing typically covers Tensile Strength, Elongation or elasticity, V-Tear, Trouser Tear and Puncture Resistance.

Tensile Strength is defined as the amount of force in pounds per square inch that is needed to stretch a medical glove until the breaking point. Higher numbers reflect superior performance. Elongation is how far the glove stretches before it breaks. For example, if a 1? sample stretches to 7? before it breaks, the elongation is 600 percent. A higher number is better because it indicates superior elasticity.

V-Tear measures the force required to initiate a tear, while trouser tear measures the force needed to continue tearing once an initial tear has been made. Puncture resistance measures the material’s ability to resist rupturing when stricken by an object.

Biocompatibility and Protection against Microorganisms
Medical gloves are also required to undergo various tests that demonstrate the potential of the material to cause irritation to the skin. These evaluations include Primary Skin Irritation tests, which demonstrate the potential for irritating abraded skin, and Dermal Sensitization testing, which indicates the potential for causing allergic contact dermatitis.

Testing is also conducted to demonstrate the ability of clothing to prevent penetration by a microorganism. This test, known as Bacteriophage Penetration Resistance, specifically measures the effectiveness of materials used in protective clothing for preventing the penetration of a surrogate microbe (Phi-X 174 bacteriophage) suspended in simulated body fluid under conditions of continuous contact. This type of testing is evaluated on a pass-fail basis.

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