(32 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.
Nitrile Patient Examination Glove, Blue or Green Colored, Prepowdered USP
This document is a 510(k) premarket notification approval letter from the FDA for Nitrile Patient Examination Gloves. It does not contain any information about acceptance criteria or a study proving device performance for a medical device in the context of AI/ML or clinical efficacy.
The letter simply states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as general controls, potential additional controls for Class II/III devices, good manufacturing practice, and labeling regulations.
Therefore, I cannot provide the requested information based on the provided text. The document is strictly for regulatory approval of a mundane medical device, not for the performance evaluation of an advanced medical device 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.