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A disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.

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The provided text is a 510(k) premarket notification letter from the FDA to Ansell Perry Incorporated for "Dermaclean X-AM™ Powder-Free Latex, Examination Gloves with Protein Labeling Claim." This document does not describe the acceptance criteria and a study proving the device meets those criteria.

Instead, it's a regulatory approval letter stating that the device is substantially equivalent to a legally marketed predicate device. It confirms the device's classification and allows the applicant to market it. The "Indications For Use" section merely states the intended purpose of the gloves.

Therefore, I cannot provide the requested information because the document does not contain:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test sets or data provenance.
• Information on experts used to establish ground truth or adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Details about the training set size or how its ground truth was established.

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