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A: The food and Drug Administration (FDA), USDA, OSHA and the American Society of Testing and Material (ASTM) set standards that glove manufacturers must meet in order to import the gloves into the U.S. market. Each of their qualifications is explained below, as well as other quality issues.
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USDA
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The USDA sets the standards for gloves to be used in food applications. All of AmerCare's gloves are manufactured to USDA specifications.
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FDA
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The FDA sets the standards of quality needed for a glove to be called medical grade. They use their tests to determine the AQL (acceptable quality level) for a glove and if four percent or less of the gloves fail, them the glove passes as a medical grade glove. They define procedures that require the use of medical grade gloves as any procedure in which a person has the chance of coming into contact with blood-borne pathogens (diseases).
The FDA has proposed some changes in the specifications for gloves to be brought into the U.S. They are proposing to lower the AQL to 2.5, have a maximum protein allowable of about 170, have a maximum powder content and also change gloves to a Class II medical device. All of these changes would drive out some of the low quality products. AmerCare is in favor of all of these changes as it will distinguish the quality companies as a "cut above".
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OSHA
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OSHA sets the standards on where medical and non-medical grade gloves can be used according to FDA definitions of a medical glove. They require use of a medical glove whenever there is patient contact.
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THICKNESS OF GLOVES
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The ASTM sets minimum standards for thickness, size and strength of gloves. The terms used in discussing thickness are either mils or millimeters.
The most common thickness for latex and vinyl is about 4.5-6 mils. There are other thickness' available but the only other major category is the 11-14 mil high-risk latex gloves.
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