(406 days)
Disposable Latex Powder Free Patient Examination Gloves (Non-sterile) Are intended for use in the medical field and worn on the examiner's hands to protect patient and user from cross contamination.
Disposable Nitrile Powder Free Patient Examination Gloves (Non-sterile) Are intended for use in the medical field and worn on the examiner's hands to protect patient and user from cross contamination.
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The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Latex Examination Gloves (Non-Sterile)" and "Disposable Nitrile Examination Gloves (Non-Sterile)."
This document does not contain information about a medical device that uses AI or machine learning, nor does it discuss acceptance criteria and study results for such a device. Instead, it is a regulatory document for standard patient examination gloves.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the given text.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.