(627 days)
A Powder Free Vinyl Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Vinyl Examination Gloves
I regret that I cannot fulfill your request to describe the acceptance criteria and study for a medical device based on the provided text. The document you've shared is an FDA 510(k) clearance letter for "Powder Free Vinyl Examination Glove" (K122377).
This type of document primarily indicates that the device has been found substantially equivalent to a legally marketed predicate device. It does not typically contain the detailed information about acceptance criteria, the specific studies performed to prove the device meets those criteria, sample sizes, expert qualifications, or ground truth establishment that you've requested.
The FDA 510(k) clearance process for Class I devices like examination gloves often relies on demonstrating equivalence to existing devices rather than requiring extensive de novo clinical trials with detailed performance metrics and statistical analyses as might be seen for higher-risk devices or novel technologies.
Therefore, the information necessary to answer your specific questions (e.g., a table of acceptance criteria and performance, sample sizes for test/training sets, details on expert ground truth, MRMC studies, standalone performance) is not available within these pages.
§ 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.