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The primaGARD Surgical Equipment Covers are Non-sterile surgical equipment covers, identified in 21 CFR, part 878.4370. The drapes are made of natural and/or synthetic material and used as a protective equipment covering. The primary purpose of this drape is to isolate equipment from contaminating the sterile field during surgery. This is to maintain the sterile technique in an operating room.

The primaGARD Surgical Equipment Covers are Non-sterile surgical equipment covers, identified in 21 CFR, part 878.4370. The drapes are made of natural and/or synthetic material and used as a protective equipment covering.

This document is a 510(k) clearance letter from the FDA for a medical device called "primaGARD Surgical Equipment Covers." It is not a study report or clinical trial document, and therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, study design, or ground truth establishment.

A 510(k) clearance signifies that the FDA has found the device to be "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness. This process typically involves demonstrating equivalence to existing devices through a comparison of technological characteristics and, sometimes, limited performance testing against established standards, but not a full-scale clinical study with the details you've requested.

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