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510(k) Data Aggregation
(296 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.
POWDER-FREE VINYL EXAM GLOVES
This document is a 510(k) premarket notification decision letter from the FDA for "POWDER-FREE VINYL EXAM GLOVES." It is not a study report or technical documentation that describes acceptance criteria for an AI/ML medical device. Therefore, I cannot extract the requested information.
The document confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It does not contain any details about performance testing, sample sizes, expert review, or ground truth establishment relevant to AI/ML device evaluation.
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(294 days)
A patient examination glove is a disposable device intended for medical purpose that A partient chanination goss hands or finger to prevent contamination between patient and examiner.
VINYL PATIENT EXAM GLOVES PRE-POWDERED, CLEAR
This document is a letter from the FDA regarding a 510(k) premarket notification for "VINYL PATIENT EXAM GLOVES PRE-POWDERED, CLEAR." It is a regulatory approval document and does NOT contain information about acceptance criteria or a study that proves a device meets such criteria.
Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence to predicate devices, not on specific performance studies or acceptance criteria for the new device.
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