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US FDA 510k and Registration for Gloves - I3CGLOBAL. Sep 21, 2020·510(k) Remarks . A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

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Evaluation of leakage in gloves (ASTM D5151): This test is intended to determine barrier evaluation of gloves by visual and leak test procedures on synthetic and latex examination and/or surgical gloves. The method consists of visual examination of the gloves, securing a test glove to a plastic cylinder, and filling the glove with 1000 mL of water.

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Medical gloves are examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations.