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Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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This document is an FDA 510(k) clearance letter for "Disposable Medical Nitrile Examination Gloves (Non sterile)". This type of medical device is a Class I device and does not involve AI/ML components for diagnosis or treatment. The content of this letter focuses on regulatory compliance for a physical product, not on the performance of a software algorithm.

Therefore, the requested information about acceptance criteria, study data provenance, expert ground truth, MRMC studies, standalone performance, training sets, etc., are not applicable to this document. These details are typically required for AI/ML-driven medical devices that output algorithmic decisions or analyses, not for physical examination gloves.

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Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Disposable Medical Nitrile Examination Gloves (Non Sterile)

This document is an FDA 510(k) clearance letter for "Disposable Medical Nitrile Examination Gloves - Non Sterile." It does not contain any information about acceptance criteria or a study proving that a device meets those criteria, as it is not for a medical device that requires such evaluation (e.g., an AI/ML-based device, an imaging system, or a diagnostic test).

The document is a clearance for a Class I medical device (non-powdered patient examination glove) which falls under general controls and does not typically require extensive performance studies or clinical trials for market clearance. The "study" in this context refers to the substantial equivalence determination made by the FDA based on the provided information, not a performance study against specific acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, or MRMC studies, as none of this information is present in the provided FDA clearance letter for examination gloves.

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Disposable Medical Examination Nitrile Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019):

The following drugs had NO breakthrough detected up to 240 minutes:

Busulfan, 6 mg/ml (6,000 ppm)
Carboplatin /Paraplatin, 10 mg/ml (10,000 ppm)
Cisplatin, 1.0 mg/ml (1,000 ppm)
Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm)
Cytarabine HCI, 100 mg/ml (100,000 ppm)
Dacarbazine, 10.0 mg/ml (10,000 ppm)
Docetaxel, 10 mg/ml (10,000 ppm)
Doxorubicin HCI, 2.0 mg/ml (2,000 ppm)
Etoposide, 20.0 mg/ml (20,000 ppm)
Fluorouracil, 50.0 mg/ml (50,000 ppm)
Ifosfamide, 50 mg/ml (50,000 ppm)
Mechlorethamine HCI, 1 mg/ml (1,000 ppm)
Methotrexate, 25 mg/ml (25,000 ppm)
Mitomycin, 0.5 mg/ml (500 ppm)
Mitoxantrone, 2 mg/ml (2,000 ppm)
Paclitaxel, 6.0 mg/ml (6,000 ppm)
Vincristine Sulfate, 1 mg/ml (1,000 ppm)

Please note that the following drug has low permeation times of less than 60 minutes:

Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes

ThioTepa10.0 mq/ml (10.000 ppm),35.7 minutes

WARNING: Do not use Carmustine and Thiotepa

The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile), a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and tested as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

This document describes the acceptance criteria and performance of "Disposable Medical Nitrile Examination Gloves (Non sterile)" (K212639).

This medical device is a Class I device and does not involve AI or human interpretation of medical images. Therefore, many of the requested categories in the prompt are not applicable. The information provided is based on the provided FDA 510(k) summary, which focuses on physical, chemical, and biological testing as per relevant ASTM and ISO standards for examination gloves.

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

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 does not explicitly state the sample sizes for each physical and chemical test (e.g., number of gloves tested for dimensions, holes, etc.). The testing was conducted according to established ASTM and ISO standards, which typically specify the required sample sizes for each test.

The data provenance is from Jiangsu Nanfang Medical Co., Ltd in China. The tests were non-clinical, laboratory-based performance tests, not involving human subjects or patient data, so the terms "retrospective" or "prospective" are not applicable in this context.

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. The "ground truth" for this device is based on objective, quantifiable physical, chemical, and biological measurements performed according to standardized testing protocols (e.g., ASTM, ISO). There is no "expert" interpretation or "ground truth" establishment in the sense of clinical image analysis or diagnosis.

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

This is not applicable as the testing involves objective laboratory measurements, not subjective evaluations or interpretation requiring adjudication.

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 device is a disposable medical glove and does not involve AI or human readers for diagnostic purposes.

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

This is not applicable. This device does not involve an algorithm or AI.

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

The "ground truth" for this medical device is based on objective measurements obtained through standardized physical, chemical, and biological testing methods (ASTM and ISO standards). Examples include:

• Precise measurements of dimensions (width, length, thickness).
• Quantifiable tensile strength and elongation.
• Measured breakthrough times for chemotherapy drugs.
• Results from established biocompatibility tests (skin irritation, sensitization, cytotoxicity) with clear pass/fail criteria.

8. The sample size for the training set

This is not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.

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

This is not applicable.

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Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile). The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I) for single use only. The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided document is a 510(k) Premarket Notification for Disposable Medical Nitrile Examination Gloves (Non-Sterile). This type of document is for a medical device that does not use AI/ML, and therefore, the requested information regarding AI/ML device performance and related study details is not applicable.

However, I can extract the acceptance criteria and performance data for this device based on the non-clinical testing summary provided.

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Medical Nitrile Examination Glove is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

The provided text describes the acceptance criteria and the study conducted for a medical device: "Disposable Medical Nitrile Examination Gloves (non-sterile)." This is a Class I medical device, and the study focused on non-clinical tests to demonstrate substantial equivalence to a predicate device, rather than the types of studies typically performed for AI/ML-based diagnostic devices. Therefore, many of the requested categories are not applicable.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of data for an AI/ML device. The tests performed are for medical gloves and involve physical and biological property assessments, not analysis of data from patients or images. The provenance of the samples (e.g., country of origin for the gloves tested) is not specified beyond the manufacturer's location (China). These were non-clinical tests.

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

Not applicable. The ground truth for the physical and biological properties of the gloves is established by standardized testing protocols (ISO, ASTM) and measurements, not by expert interpretation of data relevant to AI/ML.

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

Not applicable. As noted above, the tests are for physical and biological properties of gloves, not for AI/ML performance requiring adjudication of interpretations.

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 medical glove, not an AI-based diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is a medical glove, not an algorithm.

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

The ground truth for the non-clinical tests is based on objective measurements and established standards for material properties (e.g., tensile strength, elongation), dimensional specifications (e.g., length, width, thickness), and biocompatibility assays (e.g., cytotoxicity, irritation, sensitization, systemic toxicity).

8. The sample size for the training set

Not applicable. This device does not involve an AI/ML algorithm requiring a training set.

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

Not applicable. This device does not involve an AI/ML algorithm.

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Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves, Non-sterile. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

The document describes the acceptance criteria and study proving the device meets them for Disposable Medical Nitrile Examination Gloves (Non-Sterile) (K211075).

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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