(162 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Pre-powdered Multi-ply Examination Glove (Natural Latex Laminated with Nitrile, Externally and Internally)
This document is a 510(k) clearance letter from the FDA for a medical device (multi-ply examination gloves). It states that the device is substantially equivalent to a pre-existing device and can be marketed. However, this letter does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about a test set, experts, adjudication, MRMC studies, standalone performance, ground truth establishment, or training sets.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory communication, not a performance study report.
§ 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.