(67 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Vinyl Powdered Patient Examination Gloves
I am sorry, but the provided text from the FDA letter about "Teh Loong Vinyl, Powdered Patient Examination Gloves" (K993847) is a clearance letter for a 510(k) submission. It confirms that the device is substantially equivalent to legally marketed predicate devices.
This type of document does not contain the detailed information necessary to answer your request about acceptance criteria, study design, expert qualifications, or comparative effectiveness. The letter is a regulatory approval, not a scientific study report.
Therefore, I cannot extract the information required to populate the table and answer the specific questions you've posed.
§ 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.