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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Powdered Latex Patient Examination Gloves

The provided text is a 510(k) clearance letter from the FDA for "POWDERED LATEX PATIENT EXAMINATION GLOVES." It outlines the regulatory status and general controls for the device but does not contain the type of AI/ML device performance study details requested.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the document does not relate to an AI/ML device and does not describe such a study.

The document states:

• Device Name: POWDERED LATEX PATIENT EXAMINATION GLOVES
• Regulation Name: Patient Examination Glove
• Regulatory Class: I
• Product Code: LYY
• Indications for Use: "A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)"

This is a traditional medical device (gloves), not an AI/ML diagnostic or prognostic tool, and therefore the concepts of "acceptance criteria" based on AI performance metrics, test/training sets, ground truth establishment, or MRMC studies do not apply to this specific FDA submission.

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A patient examination gloves 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 Latex Patient Examination Gloves

The provided document is a 510(k) premarket notification for a Powdered Latex Examination Glove. This product is a medical device, but it is not an AI/ML-driven diagnostic or treatment device. The 510(k) clearance process for such a device primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria in the manner of AI/ML algorithms.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this document.

The document essentially states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and safety and effectiveness profile as a device already on the market. The "acceptance criteria" here would be meeting the requirements for substantial equivalence as defined by the FDA.

Ask a specific question about this device