(65 days)
This non-sterile 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.
Powder Free Nitrile Examination Glove Coated with Cucumber (Blue & Green)
This document is a 510(k) clearance letter from the FDA for a medical device: "Powder Free Nitrile Examination Glove Coated With Cucumber (Blue & Green)". It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical or performance study report for AI/software-based medical devices.
Instead, this document focuses on confirming that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics. The 510(k) process primarily relies on demonstrating equivalence rather than requiring extensive new clinical performance studies that establish acceptance criteria as you've outlined.
Therefore, I cannot provide the requested information based on this document. The sections you asked for, such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, are typically found in detailed performance studies for devices that require more complex validation, often software or AI-based. This document pertains to a physical medical glove.
§ 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.