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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Green Nitrile Examination Gloves

This FDA letter (K981674) is a 510(k) clearance for "Powdered Green Nitrile Examination Gloves." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. This type of clearance typically relies on demonstrating substantial equivalence to a predicate device, rather than detailed performance study data against specific acceptance criteria.

Therefore, I cannot extract the requested information from the provided text.

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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Green Nitrile Examination Gloves

This document is an FDA 510(k) clearance letter for Powdered Green Nitrile Examination Gloves. It does not contain any information about acceptance criteria or a study proving device performance, and therefore, the requested table and study details cannot be extracted from the provided text.

The document states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This determination is based on the device's indications for use and compliance with general controls provisions of the Act, including good manufacturing practices.

To answer your request, information about performance testing (such as barrier integrity, strength, biocompatibility, etc.) would need to be present in the original 510(k) submission, which is not provided here.

Ask a specific question about this device