(249 days)
A 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. Additionally, this device has the added component of a measuring tape to aid clinicians in the measurement of cervical dilation.
DilaCheck™ Nitrile Powder Free Examination Glove, (Sterile)
The provided document is a 510(k) premarket notification letter from the FDA regarding a patient examination glove, specifically the "DilaCheck™ Nitrile Powder Free Examination Glove, (Sterile)".
This document does NOT contain information about a medical device that utilizes artificial intelligence (AI) or machine learning (ML), nor does it describe a study involving a test set, ground truth experts, or statistical performance metrics like sensitivity, specificity, or AUC.
The document grants substantial equivalence to a predicate device for a physical product (a glove with a measuring tape component), not a software or AI-driven diagnostic or prognostic tool. Therefore, it does not include the type of information requested in your prompt regarding acceptance criteria and studies proving device performance for an AI/ML device.
To directly answer your prompt based on the provided document, I must state that the requested information is not present. The document pertains to a Class I medical device (gloves) and focuses on regulatory clearance for manufacturing and marketing, not on the performance evaluation of a complex diagnostic or AI system.
§ 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.