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The Stryker T4 Hood, Zippered Toga, and Pull-over Toga are components of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The Stryker T4 Personal Protection System: Stryker T4 Hood, Zippered Toga, and Pull-over Toga

This document is a 510(k) clearance letter from the FDA for a medical device called the "Stryker T4 Hood, Stryker T4 Zippered Toga, Trade Name: Stryker T4 Pull". It acknowledges that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria for the device's performance, nor does it describe any study conducted to prove the device meets such criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness. It does not typically involve detailed performance studies with acceptance criteria in the same way a Premarket Approval (PMA) application would for high-risk devices.

Therefore, I cannot provide the requested information based on the provided text. The document is solely an FDA clearance letter.

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