(84 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand on finger to prevent contamination between patient and examiner.
Pre-Powdered Latex Examination Gloves With Protein Labeling Claim (180 us
The provided document is an FDA 510(k) clearance letter for a medical device: "Pre-Powdered Latex Examination Gloves with Protein Labeling Claim, Contains 180 Micrograms or Less of Total Water Extractable Protein Per Gram".
This document describes the regulatory clearance of a physical medical device (gloves), not an AI/ML-driven device. Therefore, the requested information regarding acceptance criteria and studies that prove an AI device meets those criteria (including sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.) is not applicable to this document.
The document indicates that the device was found "substantially equivalent" to legally marketed predicate devices, meaning it does not require new clinical studies to prove effectiveness or safety in the same way an AI device would. The core "acceptance criteria" here relate to meeting the specifications of a predicate device and complying with general controls for medical devices (e.g., manufacturing practice, labeling).
In summary, none of the specific AI/ML-related questions can be answered from this document because it pertains to a different type of medical 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.