(45 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 POWDER FREE VINYL SYNTHETIC EXAM GLOVES
This document is a 510(k) clearance letter from the FDA for "Disposable Powder Free Vinyl Synthetic Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices.
Based on the provided text, none of the requested information about acceptance criteria and study details is available. This document is a regulatory approval letter, not a scientific study report. It states that the device is "substantially equivalent" to predicate devices, which implies that it meets recognized standards for examination gloves, but it does not detail specific performance criteria or a study conducted by the manufacturer to prove those criteria.
Therefore, I cannot populate the table or answer questions 2 through 9.
§ 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.