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The Medline Isolation Gown is a single use, non-surgical apparel intended to be worn by healthcare professionals to protect both the patient and the healthcare professionals from the transfer of micro-organisms, body fluids, and particulate matter. The Medline Isolation Gown meets AAMI PB70 Level 3

Medline Isolation Gown NONL V315, NONL V315XL, NONL V325, NON325XL, NONLV350XL, NONLV351, NONLV351, NONL V351XL

I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) summary for a Medline Isolation Gown, indicating FDA clearance, but it does not contain any details about the acceptance criteria or a study with performance metrics.

The text only provides:

• FDA communication regarding the 510(k) clearance.
• The device name (Medline Isolation Gown) and its various product codes.
• Indications for use: "a single use, non-surgical apparel intended to be worn by healthcare professionals to protect both the patient and the healthcare professionals from the transfer of micro-organisms, body fluids, and particulate matter. The Medline Isolation Gown meets AAMI PB70 Level 3."

The crucial information about specific performance metrics, sample sizes, expert qualifications, ground truth, or study design (like MRMC or standalone) is absent from the provided document. The mention of "AAMI PB70 Level 3" for the gown performance is a standard, but the document does not detail how Medline proved it met this standard, nor the specific acceptance criteria for that proof.

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