(53 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE VELLOW
This document is an FDA 510(k) clearance letter for "Synthetic Vinyl Patient Exam Gloves Powder-Free Yellow." It is a regulatory document and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML or diagnostic device.
Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them because the provided text does not contain this information.
The document primarily focuses on:
- The FDA's determination of substantial equivalence for the gloves to legally marketed predicate devices.
- Regulatory requirements for marketing the device.
- The intended use of the patient examination gloves (preventing contamination between patient and examiner).
To answer your request, I would need a document related to an AI/ML or diagnostic device that describes performance studies, acceptance criteria, and ground truth establishment.
§ 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.