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The Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a non - sterile disposable I no religio intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)

I am sorry, but the provided text does not contain the information requested regarding acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for a Nitrile Powder-Free Examination Glove, confirming its substantial equivalence to a predicate device. It defines the device's indications for use and general regulatory information but does not include any performance study details or acceptance criteria tables.

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The Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a "Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (blue)".

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It details regulatory requirements and contact information for further inquiries.

The "Indications for Use" section specifies the intended purpose of the glove: "a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."

Because the document pertains to a Class I medical device (patient examination glove), the regulatory pathway does not typically involve the kind of detailed performance studies and acceptance criteria that would be required for more complex devices or software as a medical device (SaMD). The substantial equivalence determination is usually based on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, and that any differences do not raise new questions of safety or effectiveness.

Therefore, none of the specific questions regarding acceptance criteria, study details, sample sizes, expert ground truth, or comparative effectiveness studies can be answered from the provided text.

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The Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)

Analysis of Information Provided:

The provided document is an FDA 510(k) clearance letter for a "Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)". This document pertains to regulatory approval for a medical device that falls under the category of patient examination gloves.

The content of this document does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device. The document is a regulatory approval for a physical medical device (gloves) and focuses on substantial equivalence to a predicate device, general controls, and compliance with specific FDA regulations for such devices.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) for an AI/ML device from this particular document.

Summary of Device and Approval:

• Device Name: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
• Regulation Number: 21 CFR 880.6250
• Regulation Name: Patient Examination Glove
• Regulatory Class: I
• Product Code: LZA
• Approval Type: 510(k) Premarket Notification (substantial equivalence)
• Indications for Use: Non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
• Type of Use: Over-The-Counter Use (21 CFR 801 Subpart C)

Conclusion regarding requested AI/ML study information:

The provided document is irrelevant to the request about acceptance criteria and studies for an AI/ML device. It is a regulatory approval for a physical medical glove.

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The Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a non - sterile disposable device intended for medical purpose that is worn on the examination between patient and examiner

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)

I am sorry, but this document does not contain the information requested. The document is an FDA 510(k) clearance letter for a Nitrile Powder Free Examination Glove, which is a medical device. It details the regulatory approval process and requirements but does not include information about acceptance criteria, study data, ground truth establishment, or sample sizes related to the performance of an AI-powered device.

Ask a specific question about this device