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Medline disposable sterile syringes are intended for use to inject fluids into, or withdraw fluids from, the body.
Medline disposable sterile insulin syringes are intended for subcutaneous injection of insulin.

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This document is primarily a 510(k) clearance letter from the FDA for Medline Piston Syringes and Medline Insulin Syringes. It states that the devices are substantially equivalent to legally marketed predicate devices.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details typically found in a clinical study report or a summary of safety and effectiveness data.

The FDA 510(k) clearance process reviews evidence of substantial equivalence to an existing predicate device, which can involve performance testing, but the specifics of how the device meets particular acceptance criteria are generally detailed in the submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information based on this document. The document confirms the FDA's decision but does not describe the underlying study details.

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