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This surgeon's glove is a device made of Synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Powder Free White Sterile Polyisoprene Surgical Gloves

This document is a 510(k) clearance letter from the FDA for Powder Free White Sterile Polyisoprene Surgical Gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information on acceptance criteria, a specific study proving the device meets the acceptance criteria, or any of the detailed study parameters requested in the prompt.

Instead, the letter primarily focuses on:

• Confirming the substantial equivalence of the device.
• Stating its regulatory classification (Class I, Product Code KGO).
• Outlining the general controls provisions of the Federal Food, Drug, and Cosmetic Act that the manufacturer must comply with.
• Providing contact information for various FDA offices.
• Listing the "Indication For Use" of the surgical gloves.

Therefore, I cannot provide the requested table and study details based on the provided text.

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