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A colored, powder free and polymer opated patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be wom on the hands or finger(s) for medical purposes to provide a bantier against potentially mlectious materials and other contaminants. The colors, pink, blue, green and violet are added respectively to the latex in the production process for the intended colored glove.

Colored Powder Free And Polymer Ceated Patient Examination Glove (Pink, Blue, Green and Violet) With A Protein Claim Of Less Than 50 pargm Glove.

This FDA clearance letter for the Glovco (M) SDN BHD Colored Powder Free and Polymer Coated Patient Examination Glove (K051345) does not contain the detailed information necessary to answer your questions about acceptance criteria and the specifics of a study proving device performance.

FDA 510(k) clearance letters primarily focus on determining substantial equivalence to a legally marketed predicate device, as opposed to providing in-depth performance study results. The letter confirms that the device is substantially equivalent for its intended use, but it doesn't typically include data tables, sample sizes, expert qualifications, or details about the method by which studies are conducted.

To answer your questions, one would need to review the actual 510(k) submission document (or similar regulatory submission) prepared by Glovco (M) SDN BHD, which would contain the performance summary and supporting data. This letter only provides a summary of the FDA's decision.

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