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DeRoyal Drapes are patient protective coverings used to isolate incision against contamination during surgical procedures.

DeRoyal will receive the nonsterile drapes from the converter made to DeRoyal's specification and use them in Convenience Kits that are sterilized, market the nonsterile to other OEM customers, and market sterile drapes individually packaged.

This appears to be an FDA 510(k) clearance letter for a medical device: "DeRoyal Drapes, Sterile, Non-Sterile".

Unfortunately, the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The letter is a regulatory document stating that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it has similar intended use, technological characteristics, and safety and effectiveness profiles as a device already on the market.

For devices cleared via a 510(k) pathway, detailed performance studies with specific acceptance criteria are typically reviewed by the FDA, but the results and methodologies of those studies are usually not included in the publicly available clearance letter itself. Instead, the applicant (DeRoyal Industries, Incorporated) would have submitted this information as part of their 510(k) submission.

Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need access to the actual 510(k) submission documents or a summary of safety and effectiveness from DeRoyal Industries for K030365.

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