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Laglove TM Brand Latex Examination Gloves, Powdered, Non - Sterile (Pink, Green, Violet) is a patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Laglove ™ Brand Latex Examination Gloves, Powdered, Non-Sterile. (Pink, Green, Violet)

This document is a 510(k) clearance letter from the FDA for medical examination gloves and does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

The letter confirms that the Laglove™ Brand Latex Examination Gloves, Powdered, Non-Sterile are substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance, labeling, and other general responsibilities under the Federal Food, Drug, and Cosmetic Act.

Therefore, I cannot provide the requested information from this document.

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