(28 days)
A blue powder-free medical glove made from synthetic nitrile latex is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluid, waste, or environment.
Blue Powder-Free Nitrile Examination Gloves
The provided document is a 510(k) premarket notification letter from the FDA for "Blue Powder-Free Nitrile Examination Gloves." This document does not contain information about a study proving the device meets specific acceptance criteria in the manner described by your request (e.g., performance metrics like sensitivity, specificity, or AUC, sample sizes for test/training sets, expert qualifications, or adjudication methods).
The letter indicates that the device has been determined to be "substantially equivalent" to legally marketed predicate devices already on the market prior to May 28, 1976. This is a regulatory pathway for medical devices where the manufacturer demonstrates that their new device is as safe and effective as an already legally marketed device, often through comparison of technological characteristics and performance data to established standards or predicate device specifications, rather than through a novel clinical study with explicit acceptance criteria for diagnostic performance metrics.
Therefore, I cannot fulfill your request for the specific study details you've asked for based on the provided text. The FDA's 510(k) clearance process for this type of device (nitrile examination gloves) typically focuses on material safety, barrier integrity, and physical properties (like tensile strength and elongation) rather than diagnostic accuracy or clinical efficacy studies with ground truth establishment as would be common for AI/diagnostic software.
If you have a document describing a performance study for a different type of device (e.g., AI-powered diagnostic software), please provide that document, and I would be happy to analyze it according to your requested criteria.
§ 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.