(94 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (Pink, Black, Grey, and Blue Peppermint Scented)
This document is a 510(k) clearance letter from the FDA for "Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs." It does not contain information on acceptance criteria for a device's performance 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.