(89 days)
The glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Glove (Blue) (This product does not contain Thiuram, and/or Carbamate and/or Thiazole)
This document is a 510(k) clearance letter from the FDA for a medical device, specifically "Powder Free Nitrile Examination Glove (Blue)". It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The information requested in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types for training and test sets) is typical for AI/ML device submissions to the FDA. However, this document pertains to a physical medical device (examination gloves) and therefore, the content does not align with the questions you've asked about AI/ML device performance.
Therefore, I cannot extract the requested information from the provided text. The document is about regulatory clearance for a traditional medical product based on substantial equivalence to existing products, not about the performance evaluation of a software algorithm.
§ 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.