(218 days)
A 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. Gloves that have been tested for use with chemotherapy drugs are not intended to be used as a chemical barrier.
Powderfree Blue Latex Examination Gloves – Tested For Use With Chemotherapy Drugs; Powderfree Natural Latex Examination Gloves - Not Tested For Use With Chemotherapy Drugs
This document is a 510(k) premarket notification letter from the FDA regarding patient examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot answer your request based on 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.