(39 days)
A powder-Free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the examiner's hand or finger's for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Powder-Free Latex Examination Gloves - Blue Color
This document is a 510(k) premarket notification letter from the FDA regarding "Ever-More Powder-Free Latex Examination Gloves-Blue Color." It confirms that the device is substantially equivalent to legally marketed predicate devices.
The letter does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.
§ 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.