(115 days)
A 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.
PATIENT EXAMINATION GLOVE, POLY (VINYL), POWDER FREE
This document is a 510(k) clearance letter from the FDA for a Poly (Vinyl) Examination Glove, Powder-Free, and primarily discusses regulatory approval. It does not contain information about specific technical acceptance criteria, a study proving performance, sample sizes for testing or training, expert qualifications, or ground truth methodologies for an AI/device performance study. Therefore, I cannot extract the requested information from the provided text.
The closest information available is the "Indications For Use" which describes the intended purpose of the glove: "A 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." This states what the device is for, but not directly measurable performance criteria from a study.
§ 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.