(56 days)
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED.
This document is a 510(k) clearance letter from the FDA for medical gloves, not a study report. Therefore, it does not contain information on acceptance criteria or a study proving device performance as requested. The letter itself is part of the regulatory approval process which attests to the substantial equivalence of the device to a predicate device already on the market, but it doesn't detail the performance tests or data, nor does it discuss AI.
Therefore, I cannot provide the requested information based on the given input.
To fulfill your request, I would need a scientific study report or clinical trial results document that describes the device's performance, acceptance criteria, and the methodology of the 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.