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510(k) Data Aggregation
(63 days)
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(43 days)
This glove is a disposable device intended for medical purpose that is worn the examiner's hand to prevent contamination between patient and examiner.
NITRILE PATIENT EXAMINATION GLOVES, POWDER FREE
The provided text is a 510(k) Pre-market Notification communication from the FDA to Asia Pacific Latex Berhad regarding Nitrile Patient Examination Gloves, Powder-Free. It is not a study or report on the performance of an AI/ML medical device. Therefore, I cannot provide the requested information as the document does not contain any details about acceptance criteria, device performance, study design, expert involvement, or ground truth for an AI/ML device.
The document is a regulatory approval letter for a physical medical device (gloves), confirming it is substantially equivalent to existing devices.
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