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Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution

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This document is a 510(k) clearance letter from the FDA for a medical device: "Biodegradable Powder Free Nitrile Examination Glove". It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The information provided describes the regulatory process (510(k) notification), classification of the device (Class I, reserved), and the general controls that apply. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

These types of details would typically be found in a separate study report or a more detailed submission document, not in the FDA's clearance letter itself.

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Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution

This document is a 510(k) clearance letter from the FDA for a new medical device, specifically examination gloves. It does not describe an AI/ML powered device, and therefore the majority of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not applicable.

However, I can extract the relevant "acceptance criteria" for the gloves in terms of their resistance to chemotherapy drugs and other solutions, as presented in the document:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for these gloves are implicitly defined by their performance against the listed chemicals, demonstrating their barrier effectiveness by reporting breakthrough times according to ASTM D6978-05 (2019). The goal is to show a reasonably long breakthrough time for protection. While specific pass/fail thresholds are not explicitly stated as "acceptance criteria" in a quantitative sense here, the reported times indicate the device's protective capabilities.

Note: The document explicitly highlights lower breakthrough times for Carmustine and Thiotepa as a "CAUTION," indicating these values are notable and potentially below a desired threshold, though a hard "failure" isn't stated for regulatory clearance.

The rest of the requested information (points 2-9) is not applicable to this document because it describes a physical medical device (examination gloves), not an AI/ML-powered software. Therefore, there is no mention of:

• Sample size used for an AI test set or data provenance.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for an AI model.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (beyond chemical testing results).
• Training set size or how its ground truth was established.

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Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors are disposable devices intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors

This document is a 510(k) clearance letter for "Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors" from Shen Wei USA Inc. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria. The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text.

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Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for "Biodegradable Powder Free Latex Examination Gloves" and discusses regulatory compliance, not performance studies of a specific AI device. Therefore, I cannot generate the requested table and study details.

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The provided text is a 510(k) clearance letter from the FDA for "Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors."

This document does not contain any information about an AI/ML medical device, its acceptance criteria, or a study proving its performance. It specifically relates to a Class I medical device (non-powdered patient examination glove) and focuses on regulatory aspects like substantial equivalence, general controls, and compliance.

Therefore, I cannot provide the requested information about acceptance criteria and a study to prove a device meets them, as the provided input does not describe such a device or study.

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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green

I am sorry, but this document contains no information regarding acceptance criteria or a study proving device performance for the "Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green" (K202085).

The document is an FDA 510(k) clearance letter, which indicates that the device has been found substantially equivalent to a legally marketed predicate device. It defines the device, its regulation, and general controls, but does not include details on performance studies or acceptance criteria beyond indicating its intended use as a medical examination glove.

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Indications for Use (Describe) CAUTION: Testing showed an average breakthrough time of 39.1 minutes for Thiotepa. WARNING: Do not use with Carmustine.

Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs

This document does not contain any information about acceptance criteria or a study related to a medical device's performance.

The provided text is a 510(k) clearance letter from the FDA to Shen Wei USA Inc. for their "Biodegradable Powder Free Nitrile Examination Glove." This letter states that the device is substantially equivalent to a legally marketed predicate device and can be marketed subject to general controls.

The document includes:

• FDA 510(k) clearance letter: This is a regulatory approval, not a performance study report.
• Indications for Use statement: This describes the intended use of the gloves, including precautions regarding specific chemotherapy drugs (Thiotepa and Carmustine).
• Paperwork Reduction Act (PRA) statement: This is a administrative notice.

There is no mention of:

• A table of acceptance criteria or reported device performance for any AI/software device.
• Sample sizes for test sets, data provenance, or ground truth.
• Expert involvement or adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Training set details.

Therefore, I cannot provide the requested information based on the given input.

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This looks like an FDA clearance letter for a medical device that does not use AI. There is no mention of acceptance criteria or a study related to AI performance. Therefore, I cannot provide the requested information about device performance against acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

The document discusses "Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color." This is a Class I medical device (non-powdered patient examination glove), which is a very low-risk device. Clearance for such devices typically involves demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical performance studies as would be required for higher-risk or AI-based devices.

The letter confirms that the FDA has reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It also outlines regulatory requirements for the manufacturer.

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I'm sorry, but this document contains a letter regarding medical device clearance (K202081) for "Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue." It discusses regulatory aspects, such as compliance with FDA regulations (21 CFR 880.6250), labeling, and reporting requirements.

However, this document does not contain any information about an AI/ML device, its acceptance criteria, or the study proving its performance. Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.

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Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid

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This document is a 510(k) clearance letter from the FDA for a medical device: "Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid."

This document does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria related to AI or algorithm performance. It is a regulatory clearance for a physical medical device (gloves), detailing the substantial equivalence determination.

Therefore, I cannot provide the requested information based on the provided text, as it does not relate to an AI/algorithm-enabled medical device study.

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