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The Effectiv The Cap is a device containing 70% Isopropy alcohol. When left in place for 5 to 10 minutes the cap decontaminates the injection port; thereafter the cap provides a physical barrier during intended use.

The Effectiv™ Cap is a cap that holds a sponge soaked with 70% Isopropyl Alcohol (IPA). The cap is provided sterile, Non-DEHP, latex free, single use, and is disposable. The Effectiv Cap is used with standard needleless ports. The Effeciv™ Cap is packaged individually, and sold in cartons.

This document is a 510(k) summary for the Effectiv™ Cap, which is a device intended to decontaminate injection ports. The document outlines the device's technical characteristics and claims substantial equivalence to predicate devices. However, it does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance beyond general cleaning and disinfection.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory classification, intended use, and comparison to predicate devices, but lacks detailed performance study results with acceptance criteria.

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