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TOP CALIBRE SDN - accessdata fda 2025

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The document is a 510(k) premarket notification submitted by Top Calibre Sdn. Bhd. for their Powder Free Latex Patient Examination Glove, which includes a protein content labeling claim and is chlorinated to contain less than 50 micrograms of water extractable protein per square inch. It outlines the device's identification, intended use, technological characteristics, and substantial equivalence to a predicate device. The FDA has determined that the glove is safe and effective for medical use, allowing it to be marketed under general controls.

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