(96 days)
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.
Patient Latex Examination Glove (Prepowdered)
This document is a 510(k) premarket notification letter from the FDA regarding a patient latex examination glove. It does not contain any information about acceptance criteria, study methodologies, device performance data, or ground truth establishment. Therefore, I cannot fulfill your request based on the provided text.
The letter merely states that the device is substantially equivalent to a legally marketed predicate device and permits its marketing. It does not include any performance data or study details.
To answer your request, I would need a document presenting the results of a device performance study, including the aspects you listed (acceptance criteria, reported performance, sample sizes, ground truth methodology, etc.).
§ 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.