(114 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.
Powder Free Polychloroprene Examination Gloves - Pink with Aloe Vera and Vitamin E
This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Polychloroprene Examination Gloves - Pink with Aloe Vera and Vitamin E." It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.
The letter is a regulatory approval for marketing the device based on a determination of substantial equivalence to previously marketed devices. It confirms that the device is a Class I medical device (patient examination glove), lists general controls it must adhere to, and provides contact information for further regulatory inquiries.
Therefore, I cannot provide the requested information as it is not present in 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.