(42 days)
Powder free vinyl 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.
Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)
This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)". It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity. This type of information is typically provided in a separate performance study report or clinical trial documentation, which is not present in these pages.
Therefore, I cannot provide the requested table or details about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.
§ 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.