(78 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250) .
Patient Vinyl Examination Gloves, Powderfree, Non-Sterile
This document is a 510(k) clearance letter from the FDA for "Patient Vinyl Examination Gloves, PowderFree, Non-Sterile." It grants market clearance based on substantial equivalence to existing devices. As such, it does not contain the detailed study information regarding acceptance criteria and performance of a new medical device that you're looking for.
Instead, this letter confirms that the device is a Class I medical device and is subject to general controls. For these types of devices, performance testing often focuses on established standards (e.g., ASTM standards for gloves) and equivalence rather than complex clinical studies with ground truth establishment and MRMC analysis.
Therefore, I cannot extract the information you requested from this document. The document primarily focuses on regulatory clearance, not detailed device performance study results.
§ 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.