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

The Disposable Medical Nitrile Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D6319 - 19, Standard Specification for Nitrile Examination Gloves for Medical Application. Disposable Medical Nitrile Examination Gloves are mainly composed of nitrile latex. It is mainly suitable for hand protection during medical examination. These gloves are powder free. The proposed device(s) are orange color and sold non-sterile and are intended to be single-use, disposable devices.

The provided document is a 510(k) Premarket Notification for Disposable Medical Nitrile Examination Gloves. This type of medical device falls under Class I, reserved, and is a non-AI/ML device. Therefore, the detailed acceptance criteria and study design elements typically associated with AI/ML device performance (such as sample size for test/training sets, expert consensus, MRMC studies, etc.) are not applicable in this context.

The document focuses on demonstrating substantial equivalence to a predicate device (K222498) through a series of bench tests and biocompatibility tests, primarily based on established ASTM and ISO standards for medical gloves.

Here's how the information provided relates to the closest equivalent of "acceptance criteria" and "proof" for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are the performance requirements set forth by relevant industry standards (ASTM, ISO). The "reported device performance" is the result of the bench tests demonstrating compliance with these standards.

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

• Sample Size: Not explicitly stated as a single number (e.g., N=X gloves). The testing is generally done on samples taken from production lots to ensure consistency. The specific sample sizes for each test are typically defined within the respective ASTM/ISO standards (e.g., AQL for freedom from holes).
• Data Provenance: The device manufacturer is Hebei Titans Hongsen Medical Technology Co., Ltd. in China. The tests were performed to demonstrate compliance with international standards (ASTM, ISO). The data is generated through prospective bench testing and biological evaluation in a controlled laboratory environment.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: For this Class I device, the "ground truth" is defined by the objective, quantifiable parameters and pass/fail criteria established in the ASTM and ISO standards for glove performance and biocompatibility. There is no need for human expert consensus on subjective interpretations, as would be the case for image-based diagnostic AI. The tests are conducted by trained technicians in accredited labs according to standardized protocols.

4. Adjudication Method for the Test Set

• Not Applicable: As the "ground truth" is based on objective measurements and predefined standard thresholds, there is no need for an adjudication method by multiple human readers. Test results are either within the acceptable range or not.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: MRMC studies are relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This is a non-AI/ML medical glove, so such a study is not applicable.

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

• Yes (in concept, but not an "algorithm"): The "standalone performance" for this device refers to its ability to meet the physical and biological requirements of the standards independently, without human interaction during "use" in a diagnostic or interpretive sense. The bench tests and biocompatibility tests effectively demonstrate this "standalone" performance against defined metrics.

7. The Type of Ground Truth Used

• Standard-based Physical and Chemical Properties / Biological Reactions: The ground truth is established by the specified acceptance criteria within the referenced ASTM (e.g., D6319-19 for physical properties, D5151-06 for holes, D6124-06 for residual powder) and ISO standards (e.g., ISO 10993-10 for sensitization, 10993-11 for systemic toxicity, 10993-23 for irritation) for medical examination gloves. These are objective, measurable physical properties and biological responses.

8. The Sample Size for the Training Set

• Not Applicable: This is not an AI/ML device, so there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

• Not Applicable: No training set exists for this type of device.

In summary, for medical gloves, the regulatory acceptance and "proof" of performance revolve around rigorous non-clinical bench testing and biocompatibility assessments against established international standards, rather than clinical studies or AI/ML specific performance metrics.

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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.

Disposable Medical Nitrile Examination Gloves

I apologize, but the provided text from the FDA 510(k) clearance letter for "Disposable Medical Nitrile Examination Gloves" does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria in the way you've outlined in your request.

The document is a standard FDA clearance letter for a Class I medical device. It primarily discusses:

• Device Name: Disposable Medical Nitrile Examination Gloves
• Regulation Number and Name: 21 CFR 880.6250, Non-Powdered Patient Examination Glove
• Regulatory Class: Class I, reserved
• Product Code: LZA
• Substantial Equivalence: Stating that the device is substantially equivalent to legally marketed predicate devices.
• General Controls Provisions: Listing requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• Indications for Use: Disposable device intended for medical purpose worn on the examiner's hand to prevent contamination between patient and examiner.

There is no mention of an AI/algorithm-based medical device, deep learning models, clinical validation studies, reader studies (MRMC), or any of the specific technical details you've requested (such as sample sizes for test/training sets, expert qualifications, ground truth establishment, or effect sizes for human readers with AI assistance).

Therefore, I cannot fulfill your request with the provided input. The information you're asking for would typically be found in detailed premarket notification submissions, clinical study reports, or performance testing summaries, which are not part of this specific FDA clearance letter.

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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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This device is intended for medical purpose that is worn on the examination between patient and examiner. In addition, these examination gloves were tested for use with the following chemotherapy drug concentrations per ASTN D6978-05(2019):

The following drugs had NO breakthrough detected up to 240 minutes:
Cisplatin, 1.0 mg/ml (1,000 ppm)
Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm)
Dacarbazine, 10.0 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)
Paclitaxel, 6.0 mg/ml (6,000 ppm)

Please note that the following drugs have low permeation times of less than 240 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 34.4minutes ThioTepa10.0 mg/ml (10,000 ppm),88.5 minutes

WARNING: Do not use with Carmustine and Thiotepa

Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs

This document describes the FDA's clearance of "Disposable Medical Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs" (K220491). This is a medical device, specifically a non-powdered patient examination glove, and the information provided details its intended use and testing against chemotherapy drugs.

This section does not contain information about an AI/ML device or its performance criteria, study design, or ground truth establishment. The document is a clearance letter for a physical medical device (gloves) and focuses on their chemical resistance properties.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device based on this input.

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This device is intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Disposable Medical Nitrile Examination Gloves

This document is a 510(k) clearance letter from the FDA for "Disposable Medical Nitrile Examination Gloves." It does not contain information about acceptance criteria or a study proving that an AI-powered device meets acceptance criteria. The document is strictly for a medical glove, which is a physical medical device, not a software or AI-driven diagnostic tool. Therefore, I cannot extract the requested information from this document.

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Ask a specific question about this device

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.

Disposable Medical Nitrile Examination Gloves

The provided FDA 510(k) clearance letter (K213912) is for "Disposable Medical Nitrile Examination Gloves." This document does not describe a software device or an AI/ML algorithm. Instead, it concerns a physical medical device.

Therefore, the requested information regarding acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details cannot be extracted from this document as it pertains to a different type of medical device altogether.

The document confirms the substantial equivalence of the gloves to a predicate device and outlines general regulatory obligations for the manufacturer. It does not contain any performance metrics or study designs related to AI/ML or diagnostic accuracy.

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This device is intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes: Cisplatin, 1.0 mg/ml (1,000 ppm); Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm); Dacarbazine, 10.0 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); Paclitaxel, 6.0 mg/ml (6,000 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), 23.9minutes; ThioTepa10.0 mg/ml (10,000 ppm),25.3 minutes. WARNING: Do not use Carmustine and Thiotepa

Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs

This document is a 510(k) premarket notification decision letter from the FDA for medical examination gloves. It does not contain any information about an AI/ML device or a study proving its performance. Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML medical device.

The document discusses:

• The clearance of "Disposable Medical Nitrile Examination Gloves - Tested for Use With Chemotherapy Drugs"
• The regulation number and product codes
• General controls provisions and other regulatory requirements for medical devices
• Indications for Use for the gloves, including specific chemotherapy drugs they were tested against and their breakthrough times.

There is no mention of acceptance criteria, study designs, sample sizes, expert involvement, ground truth, or any other elements related to the evaluation of an AI/ML-driven medical device.

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The Disposable Medical Nitrile Examination Gloves is 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 (Model: XYS-001, Size Large) is a patient examination qlove and it is made from nitrile compound. It is a single-use, powder-free and nonsterile product. The glove is worn on the examiner's hand to prevent contamination between patient and examiner, and this device meets all the requirement specifications in the ASTM D6319-19 Standard.

The provided text describes the 510(k) clearance for "Disposable Medical Nitrile Examination Gloves (Model: XYS-001)". This is a Class I medical device (non-powdered patient examination glove), and the submission focuses on demonstrating substantial equivalence to a predicate device.

The "study" described is a series of non-clinical bench tests and biocompatibility tests conducted to meet specific performance standards and criteria. There is no multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance study, or training set information as this is not an AI/software device.

Here's the breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Freedom from Holes: 200 samples tested.
• Physical Dimension Test: 13 samples tested/size (only "L" size reported in summary).
• Physical Requirement Test: 13 samples tested/L size.
• Powder Free Gloves: 5 samples.
• Biocompatibility Tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity): The specific sample sizes for animals or cell cultures are mentioned within the "Test method" description (e.g., L-929 cells, guinea pigs for sensitization, rabbits for intracutaneous, mice for systemic toxicity - usually groups of 3-5 for initial tests, or 10 for repeat tests according to the standards).
• Data Provenance: Not explicitly stated (e.g., country of origin for the testing labs), but the submitter's address is in Anhui Province, China. The studies are retrospective in the sense that they were completed tests submitted as evidence of performance.

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

Not applicable. This device is a medical glove, and the "ground truth" is established by standard laboratory testing methodologies and objective measurements against defined standards (ASTM and ISO). There are no human experts "establishing ground truth" in the diagnostic sense for this type of device.

4. Adjudication Method for the Test Set

Not applicable. The tests are benchtop, objective measurements with pre-defined pass/fail criteria from international standards. There is no subjective human assessment requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or AI devices where human reader performance is being evaluated with and without AI assistance. This device is a physical barrier (glove).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This is not an AI/software device.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation is based on objective measurements against established international standards and specifications (e.g., ASTM D6319-19 for chemical and physical properties, ASTM D5151 for freedom from holes, ASTM D6124 for powder residue, and ISO 10993 series for biocompatibility).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/software device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/software device.

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