(339 days)
Powder-Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder-Free Nitrile Examination Glove
The provided text is a 510(k) summary for a medical device (Powder-Free Nitrile Examination Gloves). It confirms the device's regulatory classification and that it has been deemed substantially equivalent to a predicate device. However, this document does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of performance metrics that would typically apply to an AI/ML or diagnostic device.
The regulatory review for these gloves focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through adherence to established standards for examination gloves (e.g., physical properties, barrier integrity, biocompatibility). The document does not describe a performance study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies that would be relevant to the questions posed.
Therefore, I cannot provide the requested information based on the input text. The questions asked are generally applicable to the validation of AI/ML-based medical devices or diagnostic tools, not to a Class I non-powdered patient examination glove.
§ 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.