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A powder-free patient examination glove is a disposable device intended for medical purpose that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner.

Powder-Free Vinyl Non-Sterile Examination Glove

The provided text is a 510(k) clearance letter from the FDA for a Powder-Free Vinyl Non-Sterile Examination Glove. This document pertains to the regulatory clearance of a medical device, specifically a physical product (gloves), and not a digital health device or AI/ML-based software.

Therefore, the requested information about acceptance criteria for a device's performance, human reader studies, AI/ML training, and ground truth establishment is not applicable to this document. The FDA letter confirms the device's substantial equivalence to a legally marketed predicate device based on its intended use as a patient examination glove to prevent contamination, and its adherence to general controls and good manufacturing practices. There is no mention of a study involving performance metrics like sensitivity, specificity, or AUC, as these are typically associated with diagnostic or AI-driven devices.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the exar iner's hand or finger to prevent contamination between patient and examiner.

Powder-Free Non-Sterile Vinyl Examination Gloves

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets any acceptance criteria. The document is a 510(k) clearance letter from the FDA for "Vinyl Exam Gloves, Powder-Free," indicating that the device has been determined to be substantially equivalent to a legally marketed predicate device.

The information provided only discusses:

• The FDA's decision to allow the marketing of the device.
• The regulatory class and product code.
• General controls provisions.
• Directions for further information or questions regarding labeling, promotion, and advertising.
• The "Indications For Use" statement for the gloves.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as this information is not present in the provided text.

Ask a specific question about this device