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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate and Other Select Drugs using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL, Gloves meet the specification of ASTM D6319 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and Select Other Drugs as per ASTM D6978. The gloves are single use, disposable, and non-sterile.

Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for length, width, thickness, etc.). However, the tests were conducted according to established ASTM and ISO standards, which typically specify appropriate sample sizes for such evaluations.

• Provenance: This information is not directly stated. The tests were conducted according to international standards (ASTM and ISO). The manufacturing company is Lingshi Hongruida Health Protection Technology Co., Ltd. located in Jinzhong, Shanxi, China. It is highly probable that the testing was performed in a laboratory either in China or an accredited facility capable of performing these international standard test methods. The study appears to be retrospective as it involves the testing of a finished device against established performance criteria.

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

This information is not applicable. The device is a physical product (nitrile gloves), and its performance is evaluated against objective, measurable criteria defined by established engineering and biological safety standards (ASTM and ISO), not subjective expert interpretation of medical images or patient data. The "ground truth" is derived from direct measurements and laboratory analyses, not expert consensus.

4. Adjudication Method for the Test Set:

This information is not applicable. As the testing involved objective physical and chemical performance standards, there was no need for expert adjudication. The results were quantifiable measurements against pre-defined acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices involving human interpretation of medical data (e.g., radiologists reading images). This product is a medical glove, and its effectiveness is determined through standardized physical, chemical, and biological testing.

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

Yes, the studies conducted are standalone performance evaluations of the physical glove itself, without any human-in-the-loop component in the evaluation of its core performance characteristics (e.g., tensile strength, resistance to chemical permeation, cytotoxicity). The testing directly measured the attributes of the glove.

7. The Type of Ground Truth Used:

The ground truth for this device's performance evaluation is based on established objective technical standards and laboratory measurements. Specifically:

• Physical properties (length, width, thickness, tensile strength, elongation) are measured directly according to ASTM D6319-19 and ASTM D412-16(2021).
• Chemical resistance (chemotherapy drug permeation) is measured according to ASTM D6978-05 (Reapproved 2019).
• Biocompatibility (skin sensitization, irritation, cytotoxicity, systemic toxicity) is evaluated through laboratory tests following ISO 10993 series standards.
• Freedom from holes is evaluated by ASTM D5151-19.
• Powder residue is evaluated by ASTM D6124-06 (Reapproved 2022).

8. The Sample Size for the Training Set:

This information is not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and quality control would involve statistical sampling typical for medical device production.

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

This information is not applicable, as there is no training set for this type of device.

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JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 23.8 Minutes Thiotepa (10 mg/ml) 24.1 Minutes

Warning: Do not use with Carmustine or Thiotepa.

The subject device in 510(K) notification K221157 is JR Medic Blue Latex Examination Powder Free Gloves tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from Natural Rubber Latex, blue color, powder free and non-sterile (as per 21CFR 880.6250, class I).

The subject device meets all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019).

The provided document describes the safety and performance testing of "JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs" to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets general acceptance criteria for a new medical device technology like an AI algorithm.

Therefore, the requested information elements related to AI/algorithm performance, such as sample size for test set with provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for the training set are not applicable to this document.

The document focuses on the physical, chemical, and biological properties of examining gloves and their resistance to chemotherapy drugs.

However, I can extract the acceptance criteria and reported device performance from the provided "G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA" section, focusing on the glove's performance criteria.

1. Table of Acceptance Criteria and the Reported Device Performance

Non-Applicable Information for this Document:

The following requested information is not applicable to the provided document as it describes the FDA 510(k) clearance for examination gloves and their resistance to chemotherapy drugs, which is a physical device, not an AI/algorithm-based diagnostic or therapeutic tool.

2. Sample size used for the test set and the data provenance: Not applicable - tests are on gloves, not a data set for an algorithm.
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 consensus, pathology, outcomes data, etc): Not applicable - "ground truth" concept does not apply in this context; instead, it's about objective physical/chemical measurements and biological responses.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

Here's a breakdown of the acceptance criteria and study information for the Nitrile Powder Free Examination Gloves, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy Drug and Fentanyl Citrate Permeation (Breakthrough Detection Time - BDT)

Note on Permeation Acceptance: For chemotherapy drugs where the predicate device showed ">240 minutes", the proposed device also achieving ">240 minutes" indicates it meets or exceeds the previous performance. For Carmustine and Thiotepa, while the BDT is lower, the acceptance is ultimately related to the explicit warning not to use them with these drugs, indicating that the observed breakthrough times are treated as insufficient for safe handling.

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

The document does not specify the exact sample sizes used for each individual test against the acceptance criteria (e.g., number of gloves tested for each physical dimension, water leak, or permeation). However, it implies standardized testing according to relevant ASTM and ISO standards. The data provenance is industrial testing, most likely performed in a lab setting, to comply with the specified ASTM and ISO standards.

• Data Provenance: The device manufacturer, Better Care Plastic Technology Co., Ltd. (located in Shenze County, Hebei, China), would have overseen these tests, either internally or through a qualified testing laboratory. The data is thus of industrial origin, specifically from the manufacturer's testing or a third-party lab they used.
• Retrospective/Prospective: These are likely prospective tests conducted specifically for this 510(k) submission to demonstrate compliance with the standards.

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

This information is not applicable to this type of device and study. The "ground truth" for examination gloves is established by objective, standardized laboratory tests (e.g., measuring physical dimensions, tensile strength, breakthrough detection time for chemicals, biological reactivity as per ISO standards). It does not involve human expert consensus on interpretations of images or clinical outcomes.

4. Adjudication method for the test set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image-based diagnostic device evaluations where expert opinions need to be reconciled. For the physical and chemical testing of gloves, the results are quantitative measurements or direct observations (e.g., pass/fail for a water leak test) and do not require expert adjudication in the same sense.

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. An MRMC study assesses the performance of human readers (e.g., radiologists, pathologists) in interpreting medical data, often with and without AI assistance, across a range of cases. This device (examination gloves) is a physical product and does not involve human readers or AI assistance in its primary function, nor in the testing performed for its clearance.

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

This is not applicable. This question pertains to AI/algorithm performance. The device is a physical product, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance of these gloves is defined by:

• Standardized Test Methods and Specifications: Specific values and criteria (e.g., minimum tensile strength, maximum powder residue, minimum breakthrough detection time) defined by national and international standards like ASTM D6319-19, ASTM D6978-05, ISO 10993 series.
• Direct Measurement and Observation: The device's physical properties and chemical resistance are directly measured and observed in laboratory settings according to these established protocols.
• Biological Reactivity Endpoints: For biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity), the "ground truth" is determined by established biological endpoints and criteria within the ISO 10993 standards.

8. The sample size for the training set

This is not applicable. This question refers to the training data for an AI algorithm. This device is a physical medical product, and no AI algorithm development is described or relevant to its clearance.

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

This is not applicable for the reasons stated in point 8.

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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 ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 23.4 minute and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 77.5 minute. Warning statements has been included.
WARNING: DO NOT USE WITH CARMUSTINE WARNING: DO NOT USE WITH THIOTEPA

Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs

The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs." This document outlines the FDA's substantial equivalence determination for this medical device.

It does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI-powered diagnostic or similar system.

Instead, the document details the "Indications for Use" for the gloves, which includes their general purpose as examination gloves and their tested performance against specific chemotherapy drugs according to ASTM D6978-05.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, or training set details) from the provided text, as these are not relevant to this type of medical device submission.

The table in the document you provided describes the "Minimum Breakthrough Detection Time (Minutes)" for different chemotherapy drugs when tested with the gloves. This is a performance specification for the gloves regarding chemical permeation, not acceptance criteria for an AI product.

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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 examination 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) >240 min.
Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) >240 min.
Dacarbazine,10.0 mg/ml (10,000 ppm) >240 min.
Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) >240 min.
Etoposide, 20.0 mg/ml (20,000 ppm) >240 min.
Fluorouracil,50.0 mg/ml (50,000 ppm) >240 min.
Paclitaxel,6.0 mg/ml (6,000 ppm) >240 min.
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7 min.
ThioTepa10.0 mg/ml (10,000 ppm), 56.9 min
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7minutes
ThioTepa10.0 mg/ml (10.000 ppm),56.9 minutes
WARNING: Do not use Carmustine and Thiotepa

Not Found

This is an FDA 510(k) clearance letter for Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs. It's a Class I reserved device and, as such, the provided information does not describe an AI/ML device but rather a physical device (gloves). Therefore, many of the requested criteria regarding AI/ML study design are not applicable.

Here's the relevant information that can be extracted from the provided text, focusing on the device's performance regarding chemotherapy drug resistance:

Acceptance Criteria and Device Performance for Chemotherapy Drug Permeation

The acceptance criteria are implicitly defined by the test results indicating "NO breakthrough detected up to 240 minutes" for most listed chemotherapy drugs, in accordance with ASTM D6978-05(2019). For drugs with breakthrough times below 240 minutes, those times are reported, along with a warning for those under 60 minutes.

Important Note: The document explicitly warns against using the gloves with Carmustine and ThioTepa due to their low permeation times (less than 60 minutes).

The following points are not applicable to this device as it is a physical medical device (examination gloves) and not an AI/ML powered diagnostic or therapeutic device. The requested information pertains to studies typically conducted for AI/ML performance evaluation.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical material testing, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material testing to a standard like ASTM D6978-05(2019) involves laboratory procedures, not expert consensus on medical images or diagnoses.
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 consensus, pathology, outcomes data, etc.): The "ground truth" used here is the physical barrier performance of the glove against specific chemical permeation, determined according to the standardized laboratory methods described in ASTM D6978-05(2019). This is a scientific, objective measurement, not based on expert consensus or clinical outcomes for diagnosis.
8. The sample size for the training set: Not applicable. This concept is for AI/ML models.
9. How the ground truth for the training set was established: Not applicable.

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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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Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)

The provided document is a 510(k) Premarket Notification for "Blue Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs." This document clears a medical device (examination gloves) for market and is not an AI/ML device study. Therefore, most of the requested information about acceptance criteria and study design for AI/ML performance is not applicable within this context.

However, I can extract information related to the performance of these physical medical gloves as detailed in the provided document, specifically related to their physical properties and chemical resistance.

Here's the relevant information based on the document:

Study Purpose: To demonstrate that the "Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy Drugs" are as safe, effective, and perform as well as the legally marketed predicate device (Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for use with Chemotherapy Drugs) K210944).

Lack of AI/ML Study: This document does not describe a study involving an AI/ML device. It pertains to a physical medical device (examination gloves). Therefore, specific criteria and study details related to AI/ML device performance (such as sample size for test/training sets for AI, data provenance for AI, number of experts for AI ground truth, human reader improvement with AI assistance, standalone AI performance) are not present in this document and cannot be provided.

Acceptance Criteria and Device Performance (for Physical Device - Gloves):

The performance of the gloves was evaluated against ASTM standards for various physical properties and for resistance to chemotherapy drugs. The acceptance criteria and reported device performance are presented in the tables below.

Table 1: Physical Properties Acceptance Criteria and Device Performance

Table 3: Chemotherapy Drug Permeation Acceptance Criteria and Device Performance

(Note: The "acceptance criteria" here is implied by the predicate device's performance for comparison, and the requirement to report the minimum breakthrough detection time. A longer time generally indicates better performance.)

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

• The document primarily refers to testing done in accordance with ASTM standards. These standards specify sample sizes for testing (e.g., for AQL testing for pinholes, or for physical properties). The exact number of samples for each specific test (e.g., how many gloves for tensile strength or how many for chemical permeation) is not explicitly stated in the summary, but it would be prescribed by the referenced ASTM standards (e.g., ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06, ASTM D6978-05).
• Data Provenance: The applicant for the device is Aspen Glove Sdn. Bhd., located in Malaysia. The testing would presumably have been conducted there or by a certified lab, but specific country of origin for the data (i.e., where the tests were physically performed) is not explicitly stated beyond the applicant's location. The testing would be prospective in nature as it evaluates the manufactured product.

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

• This is not applicable as this is a physical medical device and not an AI/ML device requiring establishment of "ground truth" by clinical experts for image interpretation or similar tasks. The "ground truth" for the physical properties and chemical resistance is established by validated laboratory testing methods conforming to recognized international standards (ASTM, ISO).

4. Adjudication Method for the Test Set:

• Not applicable. This is not a study requiring adjudication of expert interpretations but rather laboratory testing against established physical and chemical standards.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is a physical medical device, not an AI/ML device that assists human readers.

6. Standalone (Algorithm Only) Performance:

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

7. Type of Ground Truth Used:

• For physical and biocompatibility properties: Ground truth is established by validated laboratory testing methods against recognized industry standards (ASTM, ISO) with numerical or pass/fail criteria.
• For chemotherapy drug permeation: Ground truth is established by laboratory testing per ASTM D6978-05 (2019), measuring the minimum breakthrough detection time.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device.

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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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