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The Biodegradable Nitrile Examination Powder Free Glove, Green is a non-sterile disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Biodegradable Nitrile Examination Powder Free Glove, Green

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Biodegradable Nitrile Examination Powder Free Glove, Green," and it details the regulatory classification, indications for use, and general controls applicable to the device.

Therefore, I cannot extract the information required to populate the requested table and answer the questions about the study.

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

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This document does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria.

The provided text is an FDA 510(k) clearance letter for a "Latex Examination Powder Free Glove, Aloe Vera" (K193150). It states that the device is substantially equivalent to legally marketed predicate devices.

This type of FDA clearance relies on demonstrating substantial equivalence to a predicate device, rather than performing specific clinical studies to meet pre-defined performance acceptance criteria as would typically be required for a novel device or AI-powered medical device.

Therefore, I cannot provide the requested information, which would typically be found in a performance study report or a different section of a submission for a device that requires such evaluation.

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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 finger to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs.

Nitrile Examination Powder Free Glove, White, Black, Orange Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue

This document is a 510(k) premarket notification clearance letter for several types of Nitrile Examination Powder Free Gloves. It does not describe an AI/ML device or a medical imaging device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, sample sizes, and expert qualifications is not applicable to this document.

The document primarily focuses on the regulatory clearance for general medical gloves and a specific type tested for chemotherapy drug permeation. The information provided relates to:

• Device Names: Nitrile Examination Powder Free Glove (White, Black, Orange) and Nitrile Examination Powder Free Glove Tested for Use with Chemotherapy Drugs (Blue).
• Intended Use: Disposable device worn on the examiner's hand to prevent contamination between patient and examiner.
• Regulatory Classification: Class I, Product Code LZA, LZC.
• Chemotherapy Drug Permeation Data (for the blue gloves only): A table listing chemotherapy drugs, their concentrations, and breakthrough detection times as per ASTM D6978-05 standard. This is the only "performance data" presented, showing how long it takes for a chemotherapy drug to permeate the glove.

Since this document pertains to physical medical devices (gloves) and not software or imaging devices, the specific questions about AI/ML performance metrics, studies, and ground truth establishment are not relevant.

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Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient. These gloves are tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Sterile Latex Surgical Powder Free Gloves is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.

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The provided document describes the FDA's 510(k) clearance for "Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs" and "Sterile Latex Surgical Powder Free Gloves". The primary "acceptance criteria" and "study" described pertain specifically to the chemotherapy drug permeation resistance of the Nitrile gloves.

Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance (for Nitrile Gloves):

Note: The document states "Please note that the following drugs have extremely low permeation times: Carmustin (BCNU) : 8.0 minutes and Thiotepa : 16.2 minutes." This implies that while the gloves offer some protection, these specific drugs have a limited breakthrough time, which would practically serve as an informal "acceptance criterion" for healthcare professionals to consider when using these gloves with those drugs. The formal acceptance criteria for breakthrough time are typically defined by a standard, but the specific numerical threshold for "acceptable" is not explicitly listed in this document beyond the measured values. The study performed adheres to the ASTM D6978-05 standard, which defines the methodology. It's implied that exceeding the 240-minute mark is generally considered excellent performance for chemotherapy drug resistance.

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

• The document states the gloves were "tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs."
• Sample Size: The exact sample size (number of gloves tested per drug) is not specified in this document. The ASTM D6978-05 standard typically dictates the sample size and methodology.
• Data Provenance: This information is not explicitly stated in the provided document (e.g., country of origin, retrospective or prospective). It is likely from the manufacturer's internal testing as part of their 510(k) submission. Given it's a submission to the FDA, the testing was likely prospective for the purpose of demonstrating compliance.

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

• This concept is not applicable to this type of device and study. The testing for chemotherapy drug permeation is a physical/chemical test performed in a laboratory setting, not an assessment requiring expert consensus on images or clinical outcomes. The "ground truth" is established by the direct measurement of drug permeation according to a standardized method (ASTM D6978-05).

4. Adjudication method for the test set:

• Not applicable. As noted above, this is a laboratory-based permeation test, not a clinical assessment requiring adjudication among multiple readers.

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 surgical glove, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies involving human readers and AI are irrelevant to its evaluation.

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

• Not applicable. This device is a physical product (gloves), not an algorithm or software.

7. The type of ground truth used:

• The ground truth is established by direct physical/chemical measurement of chemotherapy drug permeation through the glove material using a standardized test method (ASTM D6978-05). This involves quantitative analysis to detect and measure the breakthrough time of the specific drugs.

8. The sample size for the training set:

• Not applicable. This device is a physical product. There is no concept of a "training set" in the context of its evaluation for chemotherapy drug permeation.

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

• Not applicable. See point 8.

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Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs glove is a disposable device intended for medical purpose 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 ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:

| | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection time in
Minutes, 0.01 ug/cm2/minute |
|---|--------------------------------------------------|-----------------------------------------------------------------------|
| 1 | Cisplatin, 1.0 mg/ml (1,000ppm) | >240 |
| 2 | Cyclophosphamide (Cytoxan),20.0mg/ml (20,000ppm) | >240 |
| 3 | Dacarbazine (DTIC), 10.0 mg/ml (10,000ppm) | >240 |
| 4 | Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 |
| 5 | Etoposide (Toposar), 20.0 mg/ml (20,000)ppm | >240 |
| 6 | Fluorouracil, 50.0 mg/ml (50,000ppm) | >240 |
| 7 | Paclitaxel (Taxol), 6.0 mg/ml (6,000ppm) | >240 |
| 8 | Carmustine (BCNU)3.3mg/ml(3,300ppm) | 0.9 |
| 9 | Thiotepa, 10.0mg/ml (10,000ppm) | 0.05 |

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes

Carmustine (BCNU)3.3mg/ml(3,300ppm) Thiotepa, 10.0mg/ml ( 10,000ppm)

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This document details the acceptance criteria and performance for "Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs" in the context of their ability to prevent permeation by chemotherapy drugs.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document specifies that the maximum testing time is 240 minutes. For Carmustine and Thiotepa, while specific acceptance criteria in the ">X" format are not given, the note highlights their extremely low permeation times, which can be interpreted as a disclosure rather than a failure of an acceptance criterion that requires >240 minutes.

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

• Sample Size for Test Set: Not explicitly stated in the provided document. The study refers to testing in accordance with ASTM D6978-05. The sample size would be dictated by the requirements of this standard.
• Data Provenance: Not explicitly stated. The testing was performed in accordance with ASTM D6978-05, which is an international standard.

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

This document describes a physical performance test for medical gloves against chemotherapy drugs, not a diagnostic or clinical AI study. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense does not apply here. The "ground truth" is the objective measurement of breakthrough time, determined by standardized laboratory procedures.

4. Adjudication method for the test set

Not applicable. This is a laboratory performance test based on a standardized methodology (ASTM D6978-05), not a situation requiring expert adjudication of subjective assessments.

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 document pertains to the physical performance of a medical device (gloves), not an AI-assisted diagnostic or imaging system 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 performance test of a medical device (gloves), not an algorithm.

7. The type of ground truth used

The ground truth used is the objective measurement of chemotherapy drug permeation breakthrough time, determined by a standardized laboratory method, specifically ASTM D6978-05. This is a quantitative, empirical measurement.

8. The sample size for the training set

Not applicable. This is a physical performance test for a medical device (gloves), not an AI model that requires a training set.

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

Not applicable. As this is not an AI model, there is no training set or ground truth for a training set in this context.

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The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.

POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND - PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Latex Examination Gloves with Aloe Vera and Protein Content Labeling Claim (50 Micrograms or Less)." This type of regulatory document concerns the substantial equivalence of a medical device to a legally marketed predicate device, primarily focusing on its safety and effectiveness for its intended use.

The document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance). These details are typically found in the supporting documentation submitted with the 510(k) application, which is not provided in this extract.

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

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Latex examination powderfree gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.

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This document is a 510(k) premarket notification letter from the FDA regarding "Top Glove Latex Examination Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram." This type of document is a regulatory approval, not a scientific study report. It confirms substantial equivalence to a predicate device but does not contain detailed information about acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and the reported device performance: This document confirms regulatory compliance, not performance data against specific criteria like sensitivity, specificity, or accuracy for a diagnostic device.
• Sample size used for the test set and the data provenance: Not applicable as no specific performance study is detailed.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• 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, as this is a medical glove, not an AI-assisted diagnostic device.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This indicates a comparison to existing, legally marketed predicate devices, rather than a novel performance study against specific acceptance criteria in the manner of an AI/diagnostic device. The "Indications For Use" section simply describes the purpose of exam gloves.

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Synthetic Vinyl Medical Examination Powdered Gloves are worn on the hands of Health care and similar personnel to prevent contamination between health care personnel and the patient.

SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES

The provided FDA 510(k) clearance letter (K993664) for "Synthetic Vinyl Medical Examination Powdered Gloves" does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc., which are typically associated with diagnostic or AI-powered devices.

Instead, this document is a clearance letter for a Class I medical device (gloves) and pertains to its substantial equivalence to a predicate device already on the market. For such devices, the primary "acceptance criteria" are related to manufacturing quality, safety (e.g., biocompatibility, freedom from harmful substances), and performance standards applicable to gloves (e.g., barrier integrity, tensile strength), rather than detailed clinical performance metrics.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976."

Therefore, I cannot provide the requested information as it is not present in the provided document. The 510(k) process for this type of device focuses on demonstrating equivalence to a legally marketed predicate, rather than an extensive clinical study with performance metrics in the way your prompt describes for AI or diagnostic devices.

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Pepper Green Mint Powdered Latex Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.

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The provided document is a 510(k) clearance letter from the FDA for "Pepper Green Mint Powdered Latex Examination Gloves." This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is a regulatory clearance for a medical device (gloves), not a performance study or a report on AI/software device validation.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document.

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Powdered Green Latex Examination Gloves (vith minimum length of 280mm) are worn on the hands of Health care and similar personnel to give an additional protection until the arm to prevent contamination between health care personnel and the patient especially for the Emergency Medical Service.

Powdered Green Latex Examination Glove

This document is a 510(k) premarket notification letter from the FDA regarding "Green Powdered Latex Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain information about acceptance criteria, device performance studies, or clinical trial details. It is a regulatory approval letter based on "substantial equivalence" to existing devices, not a report on a new device's performance against specific criteria.

Therefore, I cannot provide the requested information from this text. The questions you've asked typically relate to detailed technical or clinical studies supporting a device's efficacy and safety, which are not present in this regulatory correspondence.

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