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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Disposable Powder Free Vinyl Exam Glove, Pink Color

This document is an FDA 510(k) premarket notification approval letter for "Disposable Powder Free Vinyl Exam Glove, Pink Color." It confirms that the device is substantially equivalent to legally marketed predicate devices.

The request asks for specific information about acceptance criteria and a study proving a device meets those criteria. However, this document is a regulatory approval letter for a medical glove, which is a low-risk device. It does not contain the detailed technical performance study information typically found in submissions for more complex diagnostic AI/ML devices.

Therefore, I cannot provide the requested information from this document, as it does not describe a study involving "acceptance criteria" for an AI/ML device, nor does it provide performance metrics, sample sizes, ground truth establishment, or expert qualifications.

The information I can extract directly from the document is:

• Device Name: Disposable Powder Free Vinyl Exam Glove, Pink Color
• Regulation Number: 21 CFR 880.6250
• Regulation Name: Patient Examination Glove
• Regulatory Class: I
• Product Code: LYZ
• Indications for Use: "A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER."

This type of device (medical gloves) is subject to general controls and substantial equivalence determination, not the kind of detailed performance study described in the prompt.

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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Disposable Powder Free Vinyl Exam Glove, Blue Color

I am sorry, but the provided document does not contain the information requested regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a "Disposable Powder Free Vinyl Exam Glove, Blue Color". It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information. It does not include details about device performance metrics, study designs, sample sizes, or expert qualifications.

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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES & Nopal + Vitamin C

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Opus-E Disposable powder Free Vinyl synthetic Exam Gloves with Nopal & Vitamin E". This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, or clinical trial details.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory declaration, not a detailed performance study summary.

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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR

This document is a letter from the FDA regarding the approval of "Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color." It grants premarket notification to Canopus Medical Supply Company Limited.

The document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence to legally marketed predicate devices, not an evaluation of performance against specific acceptance criteria for this new device.

Therefore, I cannot provide the requested information from this document.

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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a letter from the FDA regarding a 510(k) premarket notification for "Disposable Powder Free Vinyl Examination Gloves, with Vitamin E." It confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory responsibilities.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.

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DISPOSABLE PATIENT EXAMINATION GLOVES IS A DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, FOR MEDICAL PURPOSES WORN ON THE BRINESE

Disposable Powder Free Vinyl Synthetic Examination Gloves, White

This FDA document, K013753, is for "Disposable Powder Free Vinyl Synthetic Examination Gloves, White". It is a 510(k) premarket notification indicating substantial equivalence to a predicate device. This type of submission, for a Class I device like examination gloves, does not typically include detailed clinical studies with specific acceptance criteria, sample sizes, or ground truth methodologies as would be found for more complex diagnostic or AI-driven medical devices.

Therefore, I cannot provide the requested information in the format of the table or answer the specific questions (2-9) because the source document does not contain this type of data.

Here's why:

• Device Type: Examination gloves are Class I devices. Their substantial equivalence is usually demonstrated through meeting recognized consensus standards for material properties, sterility (if applicable), and physical performance (e.g., tensile strength, barrier integrity).
• 510(k) Process for Class I Devices: For many Class I devices, the 510(k) submission primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through bench testing and adherence to standards, rather than complex clinical trials involving patient outcomes or expert interpretations. The "performance data" for such devices would typically be laboratory test results against established ASTM or ISO standards.

If this were an AI-driven diagnostic device, the requested information would be highly relevant and often found in the 510(k) summary or associated documents. However, for a Class I examination glove, the information you're asking for isn't part of the regulatory review process in the same way.

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