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510(k) Data Aggregation
(49 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Powder Free Yellow Synthetic Vinyl Patient Examination Gloves
The provided text is a letter from the FDA regarding the 510(k) premarket notification for "Powder Free Yellow Synthetic Vinyl Patient Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in the 510(k) submission itself or in detailed study reports, not in the FDA's regulatory clearance letter.
Therefore, I cannot provide the requested information based on the input text.
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(42 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.
Synthetic Powder Free Vinyl Patient Exam Gloves
This document is a 510(k) premarket notification for a medical device: "Powdered Free Synthetic Vinyl Examination Glove," regulated under 21 CFR 880.6250 (Patient Examination Gloves). The FDA letter indicates that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The document is a regulatory clearance letter, not a technical study report.
Therefore, I cannot fulfill your request for the detailed information outlined in points 1 through 9. The document only confirms the device's regulatory classification and that it can be marketed.
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