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Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs. These gloves were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination.

Here's the analysis of the provided text regarding acceptance criteria and the study:

The provided document is an FDA 510(k) clearance letter for a medical device: "Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs".

The document does not describe a study that uses an AI/ML algorithm, nor does it involve human readers, ground truth establishment through expert consensus or pathology for a diagnostic imaging device. Instead, it describes a physical characteristic test for a surgical glove.

Therefore, many of the requested points are not applicable to this document. I will focus on what is relevant to the provided text.

This document describes the testing performed on a surgical glove to assess its permeation by chemotherapy drugs.

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

Based on the provided information, the acceptance criteria are not explicitly stated as quantitative thresholds for "minimum breakthrough detection time" in a formal table like in a software performance study. Instead, the performance is reported against a specific standard and then followed by a warning. The implication is that a higher breakthrough time is better.

Note regarding acceptance criteria: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of 13.1 minutes and 15.7 minutes respectively. WARNING: Do Not Use With: Carmustine and Thiotepa." This implies that while the gloves were tested with these drugs, their performance was deemed insufficient for safe use, leading to a "Do Not Use" warning. Therefore, for Carmustine and Thiotepa, the implicitly accepted performance might be "not usable," despite the test results being reported. For other drugs, ">240 minutes" is the reported performance and implicitly acceptable for use.

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

The document primarily refers to the "Latex Powder Free Surgical Glove" as a single device type. It does not provide specifics on the sample size (e.g., number of gloves tested) for the chemotherapy drug permeation test.
The testing method referenced is ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This is a standardized, laboratory-based physical test.
The data provenance is not explicitly stated in terms of country of origin but is from the manufacturer's testing to support the 510(k) submission. This is a prospective test in the sense that the testing was performed specifically to evaluate the device against this standard.

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)

This is not applicable. This is a physical test of a device's barrier properties, not a diagnostic or AI/ML study requiring expert ground truth establishment. The "ground truth" is determined by the objective measurement of breakthrough time according to the ASTM standard.

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

This is not applicable. Adjudication methods are relevant for human-interpreted data, such as medical image analysis, not for standardized physical property testing of a 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

This is not applicable. This is a physical product, not an AI/ML algorithm or a diagnostic device involving human readers.

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

This is not applicable. This is not an algorithm. The "standalone performance" here would be the glove's permeation resistance under the specified test conditions.

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

The "ground truth" for this test is established by the objective measurement of chemical permeation through the glove material using a standardized laboratory method (ASTM D6978-05). It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. There is no AI/ML algorithm involved, and therefore no training set.

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

This is not applicable for the same reason as point 8.

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Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs -(Lemon Green) 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. It is also tested to be used against Chemotherapy Drugs.

The list of Chemotherapy Drugs tested (with breakthrough times) is as below:

Carmustine (3.3 mg/ml) 5.4 minutes
Cisplatin (1.0 mg/ml) > 240 minutes
Cyclophosphamide (20.0 mg/ml) > 240 minutes
Dacarbazine (10.0 mg/ml) > 240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml) > 240 minutes
Etoposide (20.0 mg/ml) > 240 minutes
Fluorouracil (50.0 mg/ml) > 240 minutes
Methotrexate (25.0 mg/ml) > 240 minutes
Mitomycin C (0.5 mg/ml) > 240 minutes
Paclitaxe 1 (6.0 mg/ml) > 240 minutes
Thiotepa (10.0 mg/ml) 35.2 minutes
Vincristine Sulfate (1.0 mg/ml) > 240 minutes

Please note that Carmustine and Thiotepa have extremely low permeation times of 5.4 minutes

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)". This document primarily concerns the regulatory approval of medical gloves and does not contain any information about an AI/ML-based medical device, its acceptance criteria, or studies proving its performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI/ML device from this document. The information requested (acceptance criteria, sample sizes, expert qualifications, ground truth establishment, MRMC studies, etc.) is specific to the development and validation of AI/ML algorithms in medical devices, which is not covered in this regulatory document for examination gloves.

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The Nitrile Powder Free Examination Glove with Colloidal Oatmeal - Lemon Green 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 Colloidal Oatmeal - Lemon Green

The provided text describes an FDA 510(k) clearance for "Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green." This document is a regulatory approval for a medical device (patient examination gloves). It does NOT contain information about an AI/ML-based medical device, a study proving device performance against acceptance criteria for an AI/ML system, or details about the development and testing of an AI algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment the way you would for an AI/ML device.

The information in the provided text relates to:

• Device Name: Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
• Regulation Number: 21 CFR 880.6250 (Patient Examination Glove)
• Regulatory Class: Class I
• Product Code: LZA
• Indications for Use: Non-sterile disposable device intended for medical purpose, worn on the examiner's hand to prevent contamination between patient and examiner.
• Use Type: Over-The-Counter Use

This is a clearance for a physical medical device, not a software or AI/ML-based device. If you have a different document describing an AI/ML device and its validation study, please provide that text.

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The Polychloroprene Powder Free Surgical Glove (Green) is made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Polychloroprene Powder Free Surgical Glove (Green) is made of synthetic rubber.

Based on the provided text, the document is a 510(k) premarket notification decision letter for a medical device: "Polychloroprene Powder Free Surgical Glove (Green)".

Crucially, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI-powered medical device.

The document is a regulatory approval letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. The "Indications for Use" section simply describes the intended use of the surgical glove (to protect a surgical wound from contamination).

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC study details or effect size on human readers.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information would typically be found in a more detailed technical report or study submission, not in the FDA's decision letter itself, especially for a Class I device like a surgical glove, which doesn't involve complex algorithms or AI performance testing.

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The Nittile Powder Free Examination Glove with Low Dermatitis Claim and Tested for Use with Chemotherapy Drugs (Blue) is a non- sterile disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs (tested with breakthrough times) as per attached table.

Nitrile Powder Free Examination Glove with Low Dernatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)

This is a 510(k) clearance letter for a medical device, specifically a Nitrile Powder Free Examination Glove. The document states that the device is "substantially equivalent" to legally marketed predicate devices. However, it does not contain the detailed information typically found in a study report regarding acceptance criteria and performance data in the structured format requested.

The document primarily focuses on the regulatory clearance for the glove, including its intended use, a list of chemotherapy drugs it has been tested against, and associated breakthrough times. It does not describe a study in the sense of an algorithm's performance, human reader studies, or training/test set details.

Therefore, I cannot provide the requested information in the structured format because it is not present in the provided text. The document refers to "tested for use with Chemotherapy Drugs" and "the list of Chemotherapy Drugs tested (with breakthrough times)", but this is a performance claim for the glove's barrier properties, not a study evaluating an AI device's performance or a diagnostic accuracy study.

Here's a breakdown of why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: While there's a table of chemotherapy drugs and their breakthrough times, these are performance characteristics of the glove's barrier function, not "acceptance criteria" and "reported device performance" in the context of a diagnostic or AI study. There's no mention of a particular acceptance threshold for these breakthrough times.

2. Sample sized used for the test set and the data provenance: Not applicable as this is not a study comparing diagnostic accuracy or AI performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here would relate to the chemical testing of the glove's permeation, which is a materials science test, not a diagnostic one.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

The document focuses on:

• Device Name: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
• Intended Use: Non-sterile disposable device for medical purposes, worn on examiner's hand to prevent contamination, and tested for use against chemotherapy drugs.
• Performance Data: Breakthrough times for various chemotherapy drugs, ranging from 10.1 minutes (Carmustine) to >240 minutes for most others.

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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.

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The Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs is a non-sterile disposable device intended for medical and dental purpose that is wor on the examiners hand to prevent contraniation total weather and examiner. It is also tested to be assess of the list of Chemotherapy Drugs tested (with breakthrough times) as per attached table. Please note that Carmustine and Thiotepa have externely low permeation times of 45.4 minutes and 30.9 minutes, respectively.

Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs

The provided document is a 510(k) premarket notification letter from the FDA to Hartalega Sdn. Bhd. for "Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs."

This document does not contain information about an AI/ML device or a study proving its performance against acceptance criteria. Instead, it details the FDA's clearance of a medical device (examination gloves) based on a determination of substantial equivalence to a predicate device.

The "acceptance criteria" discussed in the document relate to the gloves' permeation resistance to chemotherapy drugs, which is a functional performance metric, not an AI/ML diagnostic or predictive metric. The study mentioned is a "Permeation Test" for these gloves, not a clinical study involving human readers or AI algorithms as described in your request.

Therefore, I cannot fulfill your request using the provided text because it does not describe an AI/ML device or a study of that nature.

Here's a breakdown of why this document doesn't fit your prompt:

• No AI/ML Device: The device is "Nitrile Powder Free Examination Gloves (Orange)". There is no mention of any artificial intelligence, machine learning, software, or algorithm.
• No Acceptance Criteria for AI/ML Performance: The acceptance criteria are "Minimum Breakthrough Time" for various chemotherapy drugs, which are physical properties of the gloves.
• No Study of AI/ML Performance: The "study" referenced is a "Permeation Test", which assesses how long it takes for chemotherapy drugs to permeate the glove material.
• No Sample Size for Test Set (AI/ML): Not applicable.
• No Data Provenance (AI/ML): Not applicable.
• No Experts for Ground Truth (AI/ML): Not applicable.
• No Adjudication Method (AI/ML): Not applicable.
• No Multi Reader Multi Case (MRMC) Study: Not applicable.
• No Standalone Performance (AI/ML): Not applicable.
• No Ground Truth Type (AI/ML): Not applicable.
• No Training Set Sample Size (AI/ML): Not applicable.
• No How Ground Truth for Training Set Established (AI/ML): Not applicable.

The table provided in the document ("Permeation Test Results of Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs") shows the results of the permeation tests against the implied criteria of preventing breakthrough within a certain timeframe (or demonstrating the breakthrough time).

If you have a document describing an AI/ML medical device and its performance study, I would be happy to analyze it according to your requested format.

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The Nitrile Powder Free Examination Glove (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 (Blue)

The provided document is a 510(k) premarket notification for a medical device: "Nitrile Powder Free Examination Glove (Blue)". This type of document is a regulatory approval, not a scientific study report describing acceptance criteria and device performance in the way a clinical trial or algorithm validation study would.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness is not available in this document.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Stating its intended use (Indications for Use).
• Outlining the regulatory requirements the manufacturer must comply with.

Here's what can be extracted from the document based on your request, along with explanations for what cannot be provided:

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

• Not Available in this document. For a medical examination glove, acceptance criteria would typically relate to physical properties (tensile strength, elongation, force at break), barrier integrity (AQL for pinholes), and biocompatibility. Performance data would show how the glove met these specific criteria. This document states substantial equivalence to predicate devices, implying these criteria were met, but does not list them or the specific performance results.

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

• Not Available in this document. This document does not detail the testing methodology or sample sizes used to demonstrate compliance with performance standards.

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 (glove) approval, not a diagnostic algorithm or image analysis tool. There is no "ground truth" established by human experts in the context of diagnostic accuracy for this device. Ground truth for a glove would relate to its physical properties and barrier integrity, which are measured objectively.

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

• Not Applicable. As above, this concept doesn't apply to the regulatory approval of an examination glove.

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 not a diagnostic device or AI algorithm for image interpretation.

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

• Not Applicable. This is not an algorithm.

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

• Not Applicable. As explained, the concept of "ground truth" in the diagnostic sense is not relevant for an examination glove. The "truth" would be objective measurements against product standards (e.g., ASTM standards for medical gloves) and biocompatibility testing. The document implies these were met to establish substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. As above, no training set or ground truth in this context.

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The Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination betwreen patient and examiner.

The Nittile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue) is a nonsterile 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 Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU) and Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue)

This document is a 510(k) premarket notification decision letter from the FDA for medical examination gloves and does not contain information about acceptance criteria or a study proving that an AI/device meets acceptance criteria. It pertains to a physical medical device (examination gloves), not a software or AI-driven device.

Therefore, I cannot provide the requested information based on the input text. There is no mention of:

• Acceptance criteria for an AI or software device.
• A study proving a device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Experts used to establish ground truth or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth.
• How ground truth for a training set was established.

The document is an FDA letter granting substantial equivalence to "Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU)" and "Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue)".

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The Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove - Lemon Green (Lavender Scent) 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.

Not Found

I am sorry, but based on the provided document, there is no scientific study or data available to describe the acceptance criteria, device performance, and other related details you requested.

The document is a letter from the FDA to Hartalega Sdn. Bhd. regarding their 510(k) premarket notification for "Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information for marketing the device.

The document does not contain:

• A table of acceptance criteria or reported device performance.
• Information about sample sizes for test sets or data provenance.
• Details on the number or qualifications of experts used for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• The type of ground truth used (pathology, outcomes data, etc.).
• Sample size for training sets.
• How ground truth for training sets was established.

This document is a regulatory clearance letter, not a scientific study report.

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