(90 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Natural Latex Examination Glove with Protein Content labeling claim 137 micrograms or less
The provided document is a 510(k) premarket notification letter from the FDA for "Health-Plus, Sanitex, Reliance Pre-Powdered Latex Examination Gloves with Protein Labeling Claim (137 Micrograms or Less)." This document is a clearance letter for a medical device (latex examination gloves) and not a study report for a diagnostic AI device. Therefore, it does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, or adjudication methods typically found in studies for AI-powered medical devices.
The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means the clearance is based on a comparison to an existing device, rather than a clinical study establishing novel performance metrics or AI capabilities.
Given the nature of the document, the requested information about acceptance criteria and a study proving the device meets them cannot be extracted.
§ 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.