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Disposable Medical Synthetic Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

The subject device in this 510(k) Notification is Disposable Medical Synthetic Nitrile Examination Gloves. Non-sterile. The subject device is a patient examination glove made from nittile and vinyl compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

The Nitrile Glove Powder Free Blue is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is powder free, non-sterile nitrile examination gloves. Following FDA Code LZA, a "nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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."