(232 days)
A patient examination glove is a disposable glove intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile Examination Powder Free Glove, Black; Nitrile Powder Free Glove, Orange
The provided text is a 510(k) premarket notification decision letter from the FDA for Nitrile Examination Powder Free Gloves. This document does not contain any information related to acceptance criteria, study details, or device performance for an AI/ML powered medical device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the input material does not pertain to such a device or study.
§ 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.