(63 days)
A Nitrile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient or victim. This specialty glove has also been tested for use with the Opioid drugs Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid.
Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
This document describes the regulatory clearance of a medical device, specifically a type of examination glove, by the FDA. It does not contain information about an AI-powered diagnostic device or a study proving its performance against acceptance criteria in the context of AI/medical imaging, as is implied by the questions asking about MRMC studies, training/test sets, and expert consensus.
Therefore, I cannot provide the requested information based on the provided text. The document is a 510(k) clearance letter for a physical product (gloves) that has been tested for resistance to certain opioids, not an AI or algorithm-driven device.
§ 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.