(173 days)
A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Textured Powder-Free Nitrile Exam Gloves (Peach)
The provided text does NOT contain information about acceptance criteria or a study that proves the device meets specific criteria.
This document is a 510(k) Premarket Notification letter from the FDA, stating that the device (Textured Powder-Free Nitrile Exam Gloves) is substantially equivalent to legally marketed predicate devices. It confirms that the device can be marketed subject to general controls.
Therefore, I cannot provide the requested information as it is not present in the given text.
The information about acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth, and training sets are typically found in the 510(k) submission itself or in a separate study report, not in the FDA's decision letter.
§ 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.