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A patient exammation glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Two subject devices are bundled into this 510(k) submission. The first is a Hycare Med+ Nitrile Examination Gloves, blue colored, non-sterile called Hycare Med+ Nitrile Examination Gloves and the second is Hycare Touch Latex Examination Gloves, Natural White, Non-Sterile with Protein Labeling Claim (50 ug/g or less) called Hycare Touch Latex Examination Gloves. The principal operation both types of patient exam gloves are to provide single use barrier protection for the wearer and each device meets all the appropriate requirement specifications for Barrier Protection and tensile properties as defined in ASTM D6319-10, Standard Specification for Nitrile Examination Gloves and ASTM D3578-19, Standard Specification for Rubber Examination Gloves. The following models are disposable, single-use examination gloves (in boxes of 50, 100 and 200) which are included in this submission: Hycare Touch Latex Examination Gloves: Latex examination gloves non-sterile powder-free polymer coated (Ambidextrous) – palm textured, Color: Natural white, Sizes: XS, S, M, L, XL Hycare Med+ Nitrile Examination Gloves: Nitrile examination gloves non-sterile powder-free (Ambidextrous) - Finger textured, Color: Blue, Sizes: S, M, L, XL, XXL