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A vinyl 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.

POWDER-FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or any study that proves the device meets specific performance criteria. The document is a 510(k) clearance letter from the FDA for "Powder-Free Vinyl Examination Gloves with Aloe Coating Inside."

The letter primarily focuses on:

• Substantial Equivalence Determination: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Classification: Identifying the device as Class I and subject to general controls.
• Compliance with Regulations: Reminding the manufacturer of their responsibility to comply with various FDA regulations (e.g., registration, listing, labeling, good manufacturing practices).
• Indications for Use Statement: Defining the intended use of the glove.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Types of ground truth used.
• Sample size for training sets or how ground truth for training was established.

This type of FDA clearance (510(k)) typically relies on demonstrating substantial equivalence to a predicate device, often through performance testing detailed in the submission, but the letter itself does not contain the specifics of those tests or their results.

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