(74 days)
This gloves disposible and intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.
SMARTTEX LATEX EXAMINATION GLOVE POWDER FREE (Green, blue and natural color)
This document is a 510(k) premarket notification decision letter from the FDA for a medical device, specifically SMARTTEX Latex Examination Gloves. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, which means it has met the regulatory requirements for general controls, but it does not detail any specific performance studies or their results.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a performance study report.
§ 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.