(39 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES
The provided documents are a 510(k) premarket notification letter for "Disposable Powdered Vinyl Synthetic Examination Gloves" and an "Indications For Use" statement.
These documents do not contain any information regarding acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic devices. They pertain to a Class I medical device (patient examination glove) which typically undergoes physical and chemical testing rather than clinical performance studies in the way an AI/ML device would.
Therefore, I cannot provide the requested information based on the input text. The information requested (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set size) is relevant for AI/ML or diagnostic device submissions, not for the type of device described in these documents.
§ 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.