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Laglove™ Brand, Colored Nitrile Examination Glove (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Laglove™ Brand Colored Nitrile (Blue) Examination Gloves (Powdered)

This document is a 510(k) clearance letter from the FDA for a medical device: "Laglove™ Brand Blue Colored Nitrile Examination Glove Powdered". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The FDA's 510(k) process is about demonstrating substantial equivalence to a previously legally marketed device, not necessarily proving that a device meets specific performance acceptance criteria via a detailed study as described in the prompt. While manufacturers submit data to support substantial equivalence, the content provided here is the outcome of that review, not the detailed study results.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is concerned with regulatory approval based on equivalence, not a performance study against specific acceptance criteria.

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