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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner. Suitable for use in medical examination, diagnostic and therapeutic procedures, as well as in the dentistry field.

Illusion Powder Free Polymer Coated Blue Scented (Grape) Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)

This document is a 510(k) premarket notification letter from the FDA regarding "Illusion Powder Free Polymer Coated Blue Scented (Grape) Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)."

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is an approval letter for a medical device (patient examination gloves), confirming that the device is substantially equivalent to legally marketed predicate devices. The letter primarily details the regulatory classification, general controls, and compliance requirements for the manufacturer.

Therefore, I cannot provide a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided text.

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