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A patient examination glove is disposable device intended for mediod purposes that is donned by the user on the hands prevent possible contamination between patient and examiner.

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This document is a 510(k) clearance letter from the FDA for a medical device: Natural Rubber Pre-Powdered Colored and Flavored Patient Examination Gloves.

Based on the provided text, there is no acceptance criteria or study information that proves the device meets specific performance criteria.

Here's why:

• 510(k) Clearance: This is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process primarily relies on demonstrating equivalence to an existing device, not necessarily on new studies proving specific performance metrics beyond what was established for the predicate.
• "Contains Claim of 150 mcgm or Less of Total Water Extractable Protein Per Gram": This is a claim about the device's composition, specifically regarding its protein content to potentially reduce allergic reactions. While it implies a target, the document does not present any study data demonstrating that this claim was met for the specific device under review. It's a characteristic of the product, not necessarily a performance acceptance criterion in the context of a clinical study or effectiveness study described here.
• Focus of the Letter: The letter's content is entirely administrative, confirming that the device is "substantially equivalent" to predicate devices and can therefore be marketed. It discusses regulatory classes, general controls, and compliance with manufacturing practices. It does not delve into detailed performance studies or their results.

Therefore, I cannot fill out the requested table regarding acceptance criteria and study data using the provided scanned document. The document describes a regulatory clearance based on substantial equivalence, not a detailed performance study.

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