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

Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove, with extractable protein content labeling claim (50 microgram per gram of glove or less)

This document is a 510(k) premarket notification clearance letter for a medical device, specifically a "Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove." The letter indicates that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

However, this type of document (a 510(k) clearance letter) does not typically contain detailed information about acceptance criteria or specific study results in the way you've requested for performance validation. Instead, it confirms that the manufacturer has submitted sufficient information to demonstrate substantial equivalence to a predicate device, often based on adherence to recognized standards and general safety/performance considerations.

Therefore, I cannot extract the specific information you are asking for (acceptance criteria table, sample sizes for test/training, expert details, adjudication methods, MRMC study results, standalone performance, or detailed ground truth methods) directly from this document. These details would typically be found in the submission's technical documentation, test reports, or clinical study summaries, which are not part of this clearance letter.

The clearance letter focuses on:

• Device Name: Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove with Extractable Protein Content Labeling Claim (50 Microgram per gram of Glove of Less)
• Regulation Number/Name: 21 CFR 880.6250, Patient Examination Glove, Class I
• Indication for Use: A disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
• Key Claim: "extractable protein content labeling claim (50 microgram per gram of glove or less)" - this implies a specific performance characteristic related to latex protein content, which is often a key criterion for latex gloves.

To answer your questions, one would need access to the actual 510(k) submission and its supporting documentation, not just the FDA's clearance letter.

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

Powder-free Latex Patient Examination Glove. with extractable protein content labelling claim (50 microgram per gram of glove or less)

The provided text is a 510(k) clearance letter from the FDA for a Powder-free Latex Patient Examination Glove. This document approves the marketing of a medical device and describes its intended use and conformance to general controls. It is not a study report that details acceptance criteria and device performance data from a specific study.

Therefore, the information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication method, MRMC study details, standalone performance, ground truth types, training set size, and ground truth establishment for training) cannot be extracted from this document.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, implying it meets the same general safety and effectiveness standards as those already on the market, but it does not present the specific results of a performance study against predefined acceptance criteria.

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

Powder-Free Nitrile Patient Examination Gove, White (non-colored) and Blue Colored

I am sorry, but based on the provided document, I cannot answer your request. The document is a letter from the FDA regarding a 510(k) premarket notification for "Powder-Free Nitrile Patient Examination Glove." It discusses the regulatory classification and marketing authorization of the device.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. These types of details are typically found in the 510(k) summary or detailed reports, which are not included in the provided text.

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

Powder-free Nitrile Patient Examination Glove, Violet Color.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) premarket notification letter for a patient examination glove, detailing its classification, regulatory requirements, and indications for use. It does not include any performance data, study designs, or details about ground truth establishment.

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Ask a specific question about this device

Ask a specific question about this device

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

Powder-free Nitrile Patient Examination Glove BLUE AND WHITE

This document is a 510(k) clearance letter from the FDA for a Powder-Free Nitrile Examination Glove. It is not a study or a technical report that would contain the detailed information requested about acceptance criteria and device performance studies.

Therefore, I cannot provide the requested information from the provided text. The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, but it does not detail the specific performance studies, acceptance criteria, or ground truth establishment that would be part of such a submission.

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

Pre-powdered Nitrile Patient Examination Glove. BLUE AND WHITE (NON-GLORED)

The provided document is a 510(k) premarket notification letter from the FDA for a Powdered Nitrile Examination Glove. It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The letter explicitly states it's a review of the company's "Section 510(k) notification of intent to market the device" and determines the device is "substantially equivalent" to legally marketed predicate devices. This indicates a traditional medical device (like gloves), not an AI/ML device that would require performance studies against specific acceptance criteria.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided text.

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

Powdered Latex Patient Examination Glove with protein content labeling claim (150 µg/g glove or less)

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for a powdered latex examination glove, and it does not contain information about acceptance criteria, study details, or performance data for a device as requested in your prompt. The letter only states that the device is substantially equivalent to legally marketed predicate devices.

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

Powder-free, Latex Patient Examination Glove with protein content labelling claim (50 ug/g glove or less).

This document is a 510(k) clearance letter from the FDA for a medical device, specifically a "Powder-Free, Latex Patient Examination Glove with protein content labelling claim (50 ug/g glove or less)."

The letter indicates that the device has been reviewed and found to be "substantially equivalent" to legally marketed predicate devices. This type of regulatory clearance does not necessarily involve a clinical study to prove performance against specific acceptance criteria in the way that a novel device might. Instead, it relies on demonstrating that the new device is as safe and effective as a device already on the market.

Therefore, for this specific submission:

• There is no explicit table of acceptance criteria and reported device performance as would be found for a new diagnostic or therapeutic device. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence to a predicate device, which would include performance benchmarks for characteristics like barrier integrity, tensile strength, and protein content. The "reported device performance" would be the results of the tests conducted by Kossan Latex Industries (M) Sdn. Bhd. to show that their glove meets these benchmarks. However, these specific test results are not detailed in the provided FDA letter.
• The document does not detail a specific "study" in the clinical trial sense for an AI device. The 510(k) process for a glove primarily focuses on performance testing (e.g., integrity and strength tests, protein content assays) against relevant standards and the predicate device.

Given the nature of a 510(k) for a patient examination glove, many of the requested fields are not applicable or the information is not present in the provided FDA clearance letter.

Here's how to address your request based on the provided document and general understanding of 510(k) approvals for such devices:

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

Note: The FDA letter confirms the device is "substantially equivalent" to legally marketed predicate devices, which implicitly means it meets industry standards and performance benchmarks for patient examination gloves. The specific test results are part of the detailed 510(k) submission, not typically included in the public clearance letter.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided FDA letter. For physical and chemical tests of gloves, sample sizes are typically determined by relevant ISO or ASTM standards (e.g., ISO 2859-1 for AQL sampling, ISO 37 for tensile properties).
• Data Provenance: Not specified, but the applicant is Kossan Latex Industries (M) Sdn. Bhd. from Malaysia. Testing would have been conducted by the manufacturer or a contracted lab. The data would be prospective, as it involves testing of the device for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable in the context of device performance testing for gloves. "Ground truth" in this context refers to standardized measurements (e.g., protein content via validated assays, physical properties via test machines). Clinical expert review is not generally used to establish performance for these types of physical/chemical properties.

4. Adjudication method for the test set

• Not applicable. Performance tests for gloves are typically objective measurements with predefined pass/fail criteria based on standards. There is no expert adjudication process for these types of tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a patient examination glove, not an AI-assisted diagnostic or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a patient examination glove, not an algorithm.

7. The type of ground truth used

• Objective Measurements/Standardized Assays: The "ground truth" for glove performance involves objective measurements of physical properties (tensile strength, elongation, barrier integrity via water leak tests) and chemical properties (extractable protein content via validated assays like modified Lowry or ELISA). Compliance with relevant ASTM or ISO standards serves as the benchmark.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device, so there is no "training set."

9. How the ground truth for the training set was established

• Not applicable. As above, no training set is involved.

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