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Surgical apparel that are intended to be worn by operating room personnel during surgical procedures to protect both the patient and personnel from transfer of microorganisms, body fluids and particulate material.

Surgeon's Gown, Poly Reinforced, Large

The provided text is a 510(k) clearance letter from the FDA for a Surgeon's Gown. This letter indicates that the device has been determined to be substantially equivalent to previously marketed devices. However, it does not contain any information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot provide the requested table and details because the source document does not contain this type of information. The FDA 510(k) clearance process, especially for devices like surgical gowns, often relies on demonstrating substantial equivalence to pre-amendment devices or previously cleared predicate devices without necessarily requiring novel performance studies with detailed statistical metrics, ground truth, or expert adjudication as would be seen for complex diagnostic or AI-driven devices.

The letter focuses on regulatory compliance and the substantial equivalence determination based on the device's intended use (surgical apparel to protect from transfer of microorganisms, body fluids, and particulate material). It doesn't elaborate on the specific tests or their results that would prove this protection in a quantifiable manner, beyond likely referring to industry standards that the gown meets.

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