(128 days)
A patient Examination Powder glove sterile 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 patient Examination Powder-Free Chlorinated glove sterile 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.
Patient Latex Examination Glove Powdered & Powder-Free, Sterile
This document is a 510(k) premarket notification decision letter from the FDA for medical examination gloves and does not contain information about acceptance criteria or a study proving device performance in the way typically expected for an AI/ML medical device.
The information provided in the document pertains to the regulatory clearance of a physical medical device (latex examination gloves) based on substantial equivalence to a predicate device, not on algorithmic performance or clinical study outcomes involving AI.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document. The concepts are not applicable to the content of the provided text.
§ 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.