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Laglove TM Brand Latex Examination Gloves, Powder Free, Non - Sterile (Pink, Green and Violet) 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 TM Brand Latex Examination Gloves, Powder Free, Non - Sterile (Pink / Green / Violet)

The provided document is a 510(k) premarket notification letter from the FDA to Laglove (M) SDN. BHD. for their "Laglove Brand Colored Latex Examination Gloves, Powder Free". This document solely concerns the FDA's determination of substantial equivalence for this medical device and does not contain information about acceptance criteria or a study proving its performance.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the device's market clearance is based on its similarity to existing, legally marketed devices, rather than on a new study proving its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information because it is not present in the given document. The document describes regulatory approval based on substantial equivalence, not a performance study.

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