(43 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 the patient and examiner.
Disposable Powder Free Vinyl Synthetic Examination Glove, White Color
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth.
The document is a letter from the FDA regarding a 510(k) premarket notification for a "Disposable Powder Free Vinyl Synthetic Examination Glove, White Color". It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. The "Indications for Use" section simply defines the intended use of the glove as a disposable device for medical purposes to prevent contamination.
Therefore, I cannot fulfill your request for a description of acceptance criteria and the study that proves the device meets them.
§ 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.