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Medline Breathable, Impervious Surgical Gowns are single-use gowns intended to be worn by operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids and particulate material.

Medline Breathable, Impervious Disposable Surgical Gowns

I am sorry, but the provided text is a letter from the FDA to Medline Industries, Inc. regarding the clearance of their Medline Breathable, Impervious Disposable Surgical Gowns. It states that the device is substantially equivalent to previously marketed devices.

This document does not contain any information about:

• Acceptance criteria and reported device performance (in table format or otherwise)
• Details of a study proving the device meets acceptance criteria
• Sample sizes or data provenance for a test set
• Number or qualifications of experts for ground truth establishment
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

Therefore, I cannot fulfill your request for this specific information based on the provided text.

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