(32 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 EYAMINER EXAMINER.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR
The provided text is a 510(k) premarket notification letter from the FDA regarding a Disposable Powder Free Vinyl Synthetic Examination Glove. It does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes, expert involvement, or any data related to the performance of an AI/ML device.
Therefore, I cannot provide the requested information. The document is a regulatory approval letter for a physical medical device (gloves), not an AI/ML algorithm requiring a performance study as described in your prompt.
§ 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.