(120 days)
The latex examination gloves is a disposable devices intended for medical, dental and laboratory purposes that is worn on the mcarear, achear and to prevent contamination between patient and examiner.
Chlorinated Powder Free Latex Examination Gloves (Yellow)
This document is a 510(k) clearance letter from the FDA for Chlorinated Powder Free Latex Examination Gloves (Yellow). It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information from this document.
§ 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.