(44 days)
Disposable Medical Synthetic Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Disposable Medical Synthetic Nitrile Examination Gloves
The provided text is a U.S. Food and Drug Administration (FDA) 510(k) clearance letter for "Disposable Medical Synthetic Nitrile Examination Gloves." This document does not describe acceptance criteria for an AI/ML device or a study proving its performance.
Instead, it's a regulatory clearance for a physical medical device (gloves), confirming its substantial equivalence to previously marketed devices. The content focuses on regulatory compliance, such as registration, labeling, manufacturing practices, and adverse event reporting for this type of conventional device.
Therefore, I cannot extract the information required to answer your questions about acceptance criteria and a study proving the device meets those criteria, as no such information is present in the provided text. The questions you've posed (regarding tables of acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) are relevant to the evaluation of AI/ML medical devices, not to the clearance of examination gloves.
§ 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.