(25 days)
Powder-free Patient Examination glove is a disposable device which is primarily Intended for modition between patient and patient and examiner's hand or finger to prevent Intended for modition between patient and examiner.
Powder-Free Latex Examination Trade Name: Gloves with 50 Micrograms or Less of Total Water Extractable Protein Per Gram
The provided text is a letter from the FDA regarding a Guthrie Prime Powder-Free Latex Examination Glove. This document is a 510(k) premarket notification and primarily focuses on the regulatory approval for this medical device, asserting its substantial equivalence to previously marketed devices.
Based on the content, this document does not contain the information needed to describe acceptance criteria and a study proving a device meets them in the context of the requested details (e.g., AI performance, expert ground truth, sample sizes for test/training sets, MRMC studies). The device mentioned is a physical product (latex gloves), not a software or AI-driven diagnostic device that would typically have such performance criteria.
Therefore, I cannot fulfill your request using the provided text. The document is about a regulatory approval for a physical medical device, not a performance study as described in your prompt.
§ 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.