(137 days)
The Powder Free Polychloroprene Examination Glove Blue or Pink, non sterile is a disposable device and is made of synthetic rubber intended for medial purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Polychloroprene Examination Glove Blue Powder Free Polychloroprene Examination Glove Pink
This document is a 510(k) premarket notification from the FDA for polychloroprene examination gloves. It is NOT a study about an AI/ML medical device. Therefore, it does not contain the information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes for test and training sets, ground truth establishment, or details about comparative effectiveness studies.
The document pertains to a Class I medical device (patient examination glove), which is subject to general controls and does not typically require the rigorous clinical study details outlined in the prompt for AI/ML devices.
§ 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.