{"id":2076,"date":"2020-04-06T15:38:29","date_gmt":"2020-04-06T15:38:29","guid":{"rendered":"https:\/\/gcttg.com\/2020\/04\/06\/evaluation-de-gants-dexamen-en-nitrile-pour-application-medicale-selon-la-specification-astm-d6319\/"},"modified":"2021-06-29T19:37:16","modified_gmt":"2021-06-29T19:37:16","slug":"performance-of-nitrile-examination-gloves-for-medical-application-in-accordance-with-astm-d6319","status":"publish","type":"post","link":"https:\/\/gcttg.com\/en\/performance-of-nitrile-examination-gloves-for-medical-application-in-accordance-with-astm-d6319\/","title":{"rendered":"PERFORMANCE OF NITRILE EXAMINATION GLOVES FOR MEDICAL APPLICATION, IN ACCORDANCE WITH ASTM D6319"},"content":{"rendered":"

This specification is intended as a referee procedure for evaluating the performance and safety of nitrile rubber examination gloves. Requirements are established for nitrile rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. Physical material tests and performance tests are covered by the specification.<\/p>\n\n\n\n\n\n\n\n
Test 1 :<\/u>\u00a0<\/u>ASTM D5151 \u2013 Detection of Holes in Medical Gloves <\/strong><\/p>\n

This test consists in submitting a glove to an internal pressure of one liter of water, an evaluating any leakage. This test detects leaking holes which thereby compromise the usefulness of the glove.\u00a0 \u00a0Adaptation of this test under pressurized conditions is recommended to evaluate smaller holes, down to the size of 21-gauge needles.<\/td>\n

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Test 2 : <\/u><\/strong>ASTM D6319 et D3767 \u2013\u00a0 Physical Dimensions of Medical Gloves <\/strong><\/p>\n

Dimensions are determined at specific locations, including glove\u2019s length, its width at the location of the palm, and its thickness.<\/td>\n

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Test 3 : <\/u><\/strong>ASTM D412 \u2013 Tensile Strength and Elongation of Elastomers<\/strong><\/p>\n

This test evaluates the tensile (tension) properties of vulcanized thermoset rubbers and thermoplastic elastomers. Specimens of uniform cross-sectional area are tested under a constant rate of elongation. For medical gloves, dumbbell (type C) specimens are cut in the flat portion from cuff edge to palm, tensile strength, and ultimate elongation are measured; a minimum strength of 14 MPa and a minimum elongation of 500% are required.<\/td>\n

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Test 4 : <\/u><\/strong>ASTM D573 \u2013 Accelerated Aging of Medical Gloves<\/strong><\/p>\n

Gloves are subjected to an oven aging and tested for tensile strength and elongation, using ASTM D412, after aging. The accelerated aging of medical gloves is 166 hours at 70\u00b0C, or otherwise 24 hours at 100\u00b0C for specific usage. A minimum residual tensile strength and ultimate elongation is required.<\/p>\n

Technical note: the observed reduction in tensile elongation is caused by oxidation and thermal aging of elastomers.<\/em><\/td>\n

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Test 5 : <\/u><\/strong>ASTM<\/strong> D6124 \u2013 Residual Powder on Medical Gloves <\/strong><\/p>\n

Solid powder content on the surface of medical gloves is determined through repetitive rinsing and filtration of solids from the inside and outside of the gloves.\u00a0 Procedure I and procedure II are adapted to measure the amount of powder per glove or the amount of powder per unit area, respectively. Gloves are assessed as powder-free gloves if the powder content is measured below 2mg per glove.<\/td>\n

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In addition to ASTM D6319, tests for nitrile gloves in medical applications are required in Canada and in USA for the following characteristics:<\/p>\n