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A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.

The provided text describes the acceptance criteria and performance of "Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs." This is a medical device, and the data presented relates to its physical and chemical properties, not an AI/ML powered device. Therefore, many of the requested fields are not applicable.

Here's the information extracted from the document based on the prompt:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size for the tests conducted to determine the breakthrough detection times or other physical properties. It generally refers to conducting tests "in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs," and other ASTM and ISO standards. These standards typically specify sample sizes for their respective tests. The provenance of the data is implied to be from the manufacturer's testing (Maxter Glove Manufacturing Sdn Bhd) in Malaysia, as they are the submitter of the 510(k). The tests are prospective in nature, as they are performed to demonstrate compliance with standards for the device being submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical device (gloves) and the "ground truth" is established through standardized laboratory testing against chemical permeation and physical properties, not through expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a physical device.

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 is a physical device, not an AI/ML powered medical device.

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

Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on objective measurements conducted according to established international and national standards (e.g., ASTM D6319-10, ASTM D5151, ASTM D6124, ASTM D6978-05, ISO 10993). This involves laboratory measurements for physical dimensions, tensile strength, elongation, freedom from holes, powder residue levels, breakthrough time for chemotherapy drugs, and biocompatibility endpoints (irritation, sensitization, cytotoxicity).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML-powered device that requires a training set.

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

Not applicable. This is a physical device.

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A powder free 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml: 1.0 minute Thiotepa, 10.0mg/ml: 31.3 minutes

These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.

This document does not describe a device that uses Artificial Intelligence (AI) or Machine Learning (ML). It is an FDA 510(k) premarket notification for Powder Free Nitrile Examination Gloves Tested For Use with Chemotherapy Drugs.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for an AI/ML device is not applicable to this document.

The document focuses on the physical and chemical properties of the gloves, primarily their resistance to permeation by chemotherapy drugs, and compares them to established ASTM standards and a predicate device.

However, to address the acceptance criteria and performance data as presented in the document for the physical device (gloves):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the gloves are primarily based on ASTM standards. The relevant performance data is provided in "Table 1" on page 4 of the document, comparing the applicant's device to a predicate device and relevant standards.

Note on Chemotherapy Drug Permeation: The "acceptance criteria" here are comparison points from the predicate device and the standard. The device performance for Carmustine and Thiotepa for the current device are lower than >240 minutes, but still considered acceptable with explicit warnings regarding their low permeation times, similar to how the predicate device also had drugs with low permeation times. For Thiotepa, the current device performance (31.3 minutes) is significantly better than the predicate (2.0 minutes). For Carmustine, the current device performance (1.0 minute) is lower than the predicate (15.0 minutes). These differences are noted and addressed by a warning statement.

This summary is based on the information provided, which details the device's compliance with established industry standards for patient examination gloves and specific testing for chemotherapy drug permeation.

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A powder free 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml (3,300ppm) Thiotepa, 10.0mg/ml (10,000ppm)

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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This document describes a 510(k) premarket notification for "Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (Non-Sterile)". The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices for general patient examination glove use, and additionally, to provide data on the gloves' resistance to permeation by chemotherapy drugs.

As such, the information provided focuses on the testing for chemotherapy drug permeation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the test standard ASTM D6978-05, which is a standard practice for assessing medical gloves for permeation by chemotherapy drugs. While the document doesn't explicitly state a "pass/fail" threshold for breakthrough time (e.g., all drugs must be > X minutes), it does highlight drugs with permeation times less than 240 minutes, implying that longer breakthrough times are generally more desirable. The reported performance is the minimum breakthrough detection time for each drug.

Note on Acceptance Criteria: The document explicitly notes: "Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml (3,300ppm) Thiotepa, 10.0mg/ml (10,000ppm)". This indicates that while the device was tested, a breakthrough time of less than 240 minutes for these specific drugs is acknowledged and disclosed, rather than being an outright "failure". The acceptance criterion is therefore the performance according to the specified ASTM standard, with the understanding that users would be informed about the permeation characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size (number of gloves or individual tests) used for the chemotherapy drug permeation testing. It only lists the results for each drug.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective". However, the manufacturer is Maxter Glove Manufacturing Sdn. Bhd. in Malaysia, suggesting the testing likely occurred in or was commissioned by the manufacturer, possibly in Malaysia or a testing lab accredited to perform ASTM D6978-05. The testing itself is a prospective performance test of the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (patient examination gloves) and the specific test (chemotherapy drug permeation) do not involve "experts" establishing a ground truth in the traditional sense of clinical diagnosis or interpretation. The "ground truth" is established by the standardized laboratory test procedure itself (ASTM D6978-05), which objectively measures the breakthrough time of the chemotherapy drugs through the glove material. The "truth" is the measured time according to the standard.

4. Adjudication Method for the Test Set

Not applicable. This is a laboratory performance test, not a subjective assessment requiring adjudication. The results are quantitative measurements.

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 is a performance test for a patient examination glove, not an AI-assisted diagnostic or interpretive device involving human readers.

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

Not applicable. This is a physical device (glove), not an algorithm or AI. The testing performed is an objective measurement of its physical properties.

7. The type of ground truth used

The ground truth used is objective laboratory measurement based on a standardized test method (ASTM D6978-05). This standard details how to measure the permeation of chemotherapy drugs through medical glove materials, providing a quantifiable breakthrough time.

8. The sample size for the training set

Not applicable. This is a physical device undergoing performance testing, not a machine learning model that requires a training set.

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

Not applicable. As this is not a machine learning model, there is no training set or associated ground truth for a training set.

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A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

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The provided text is a 510(k) clearance letter from the FDA for a medical device (Maxter Powder Free Nitrile Medical Examination Gloves). It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

This type of document is a regulatory approval, confirming that the device is "substantially equivalent" to a legally marketed predicate device. It typically doesn't detail the specific testing methodologies or results that would be found in a study report.

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

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A Sterile Powder Free Latex Surgical Glove is a disposable device made of natural rubber latex and is intended to be worn by operating room personnel to protect a surgical wound from contamination.

Sterile Powder Free Latex Surgical Gloves

The provided document is a 510(k) substantial equivalence determination letter from the FDA for Maxter Sterile Powder Free Latex Surgical Gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this letter does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. These details would typically be found in the 510(k) submission itself or a separate study report, which is not provided here.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is essentially the FDA's approval notice, not the technical submission with performance data.

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A Sterile Powdered Latex Surgical Glove is a disposable device made of natural rubber latex and is intended to be worn by operating room personnel to protect a surgical wound from contamination.

Sterile Powdered Latex Surgical Gloves

The provided document is an FDA 510(k) clearance letter for "Maxter Sterile Powdered Latex Surgical Gloves." This document does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.

The document pertains to a medical device (surgical gloves) that undergoes a different type of regulatory review than AI/ML software. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, primarily based on its materials and intended use, rather than performance metrics derived from complex data analysis.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) from this document. This kind of information is typically found in premarket submission summaries for AI/ML devices, not for basic medical consumables like surgical gloves.

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A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Chlorinated Powder Free Latex Medical Examination Gloves with 50 Micrograms or Less of Total Water Extractable Protein per gram.

The provided document (K013498) is a 510(k) premarket notification letter from the FDA regarding "Chlorinated Powder Free Latex Medical Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)." This document is a regulatory approval letter and does not contain information about acceptance criteria or studies proving a device meets acceptance criteria in the context of a modern AI/ML medical device.

The information requested, such as a table of "acceptance criteria and reported device performance," "sample sizes for test set and training set," "ground truth establishment," "MRMC studies," etc., are typical requirements for evaluating the performance of AI/ML-driven medical devices or diagnostic tools.

The document pertains to a physical medical device (examination gloves) and its approval is based on a "substantial equivalence" determination to legally marketed predicate devices, rather than a performance study involving statistical metrics common for AI/ML.

Therefore, it is not possible to answer the requested questions based on the provided text, as the document does not describe such studies or criteria.

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A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Polymer Coated Powder Free Latex Medical Examination Gloves with 50 Micrograms or Less of Total Water Extractable Protein per g.

This document is an FDA 510(k) clearance letter for "Polymer Coated Powder Free Latex Medical Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)." This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed acceptance criteria or study results in the format requested.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined the new device is as safe and effective as a device that is already on the market. The specific data that led to this determination, including detailed acceptance criteria and study designs, would be found in the 510(k) submission itself, not in this clearance letter.

To fully answer your request, one would need access to the actual 510(k) submission (K013554) filed by Maxter Glove Manufacturing Sdn. Bhd., which is not provided in the given text.

Therefore,Based on the provided document, I cannot generate the requested information about acceptance criteria and study details.

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A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Powdered Latex Medical Examination Gloves with 150 Micrograms or Less of Total Water Extractable Protein per Gram of Glove.

This document is an FDA 510(k) clearance letter for Powdered Latex Medical Examination Gloves. It does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed, but does not provide specific data from performance studies.

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

Ask a specific question about this device