(84 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Sterile Nitrile Examination Gloves (Powdered)
This document is an FDA 510(k) clearance letter for Smart Glove Sterile Nitrile Examination Gloves. The information provided outlines the regulatory acceptance for the device, but does not contain any data from a study that proves the device meets specific acceptance criteria in the manner of an AI/ML algorithm evaluation.
Instead, the letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for medical devices based on comparison to existing products, rather than through a standalone performance study with detailed acceptance criteria and reported metrics in the context you're asking.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test and training sets, or data provenance.
- Details on experts, ground truth establishment, or adjudication methods.
- Information on MRMC or standalone performance studies, or effect sizes.
This document focuses solely on the regulatory clearance process for a physical medical device (gloves), not the performance evaluation of a software or AI/ML 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.