(134 days)
A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hands or finger(s) to prevent contamination between patient and examiner.
POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
This document is a 510(k) clearance letter from the FDA for Powder-Free Nitrile (Black) Examination Gloves. It does not contain the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device or AI system.
The text explains that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It does not include any performance data or study details typically found in a summary of safety and effectiveness.
Therefore, I cannot fulfill your request for the specific information.
§ 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.