(85 days)
A patient examination Latex Powder Free Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Latex Powder Free Examination Gloves
This document is an FDA 510(k) clearance letter for "Latex Powder Free Examination Gloves". It does not contain information about acceptance criteria and a study proving a device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot extract the requested information as it is not present in the provided text.
§ 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.