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The 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.

The glove was tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2023).

The subject device is single use, disposable and non-sterile gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder free, ambidextrous with beaded cuff, Blue/Black colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in six sizes: XS, S, M, L, XL, XXL.

This FDA 510(k) summary describes the acceptance criteria and the study results for the Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K242936).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Black Gloves:
Carmustine: 22.6 min
Cisplatin: >240 min
Cyclophosphamide: >240 min
Dacarbazine: >240 min
Doxorubicin HCL: >240 min
Etoposide: >240 min
Fluorouracil: >240 min
Methotrexate: >240 min
Paclitaxel: >240 min
Thiotepa: 35.6 min
Fentanyl Citrate: >240 min |
| ISO 10993 Part 10-2021 - Biocompatibility | | | |
| Skin Sensitization Testing | Skin Sensitization Testing | Under the conditions of the study, the device is not a sensitizer | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test. |
| ISO 10993 Part 23-2021 - Biocompatibility | | | |
| Skin Irritation Testing | Skin irritation Testing | Under the conditions of the study, the device is not an irritant | The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.0 for the SC and SO test article extracts, respectively. |
| ISO 10993-5:2009 - Biocompatibility | | | |
| Cytotoxicity testing | Cytotoxicity testing | No Cytotoxicity reactivity (note: text says "No Cytotoxicity reactivity" but result section shows some initial toxicity addressed by further testing) | The test article extract showed evidence of causing severe cell lysis or toxicity. Toxicity concerns was addressed by Acute Systemic Toxicity testing. |
| ISO 10993-11:2017 - Biocompatibility | | | |
| Acute systemic toxicity study | Acute systemic toxicity study | Subject showed no adverse biological reaction | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. |

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

The document does not explicitly state the sample sizes for the test sets for each specific test (e.g., how many gloves were tested for length, how many for water leak). However, the standard ASTM D6319-19(2023) and other listed standards would define the required sample sizes for each test to ensure statistical validity.

The data provenance is not explicitly stated in terms of country of origin of the data or retrospective/prospective. However, the tests are "non-clinical tests" conducted to verify design specifications and conform to international and national standards (ASTM, ISO). This suggests the data was generated through controlled laboratory testing following these specified methodologies.

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

This device is a medical glove, and its performance evaluation primarily relies on objective, standardized laboratory tests against defined physical, chemical, and biological endpoints, not subjective expert assessment of images or clinical cases. Therefore, the concept of "experts establishing ground truth for a test set" as typically understood in AI/imaging studies does not apply here. The "ground truth" for these tests is the quantitative measurement results compared to the established thresholds defined by the standards.

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

Not applicable. As mentioned above, the evaluation relies on objective analytical tests rather than subjective human assessment 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:

Not applicable. This device is a medical glove, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" for the performance evaluation of these gloves is based on objective measurements and chemical analysis as defined by the referenced ASTM and ISO standards. For example:

• Physical properties (length, width, thickness, tensile strength, elongation): Measured values compared to a numerical range or minimum defined by ASTM D6319.
• Freedom from holes (water leak test): Objective criteria (AQL 2.5) for defect detection.
• Powder residue: Quantitative measurement (Max 2mg/glove).
• Chemical permeation (chemotherapy drugs and Fentanyl Citrate): Directly measured breakthrough detection time (BDT) in minutes, as per ASTM D6978.
• Biocompatibility (Sensitization, Irritation, Cytotoxicity, Systemic Toxicity): Laboratory test results demonstrating lack of adverse biological reactions as defined by ISO 10993 standards and evaluated against established pass/fail criteria (e.g., no evidence of sensitization, no irritancy, no mortality/toxicity).

8. The sample size for the training set:

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

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

Not applicable. This is not an AI/machine learning device.

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The Powder Free Nitrile Examination Gloves (Blue) , Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. The tested chemotherapy drugs are: Carmustine 3.3 mg/ml(3,300 ppm) 27.7 (35.5,27.7,27.7) Cisplatin 1 mg/ml (1,000 ppm) >240min Cyclophosphamide 20 mg/ml (20,000 ppm) >240min Dacarbazine 10mg/ml (10,000 ppm) >240min Doxorubicin HCl 2 mg/ml(2,000 ppm) >240min Etoposide 20 mg/ml (20,000 ppm) >240min Fluorouracil 50mg/ml(50,000 ppm) >240min Gemcitabine HCl 38 mg/ml (38,000 ppm) >240min Ifosfamide 50mg/ml (50,000 ppm) >240min Methotrexate 25mg/ml (25,000 ppm) >240min Mitomycin C 0.5 mg/ml(500 ppm) >240min Mitoxantrone HC1 2 mg/ml (2,000 ppm) >240min Paclitaxel 6 mg/ml (6,000 ppm) >240min Thiotepa 10 mg/ml (10,000 ppm) 59.4(67.5,59.4,65.9) Vincristine Sulfate 1 mg/ml (1,000 ppm) > 240min The tested non-chemotherapy drugs are: Fentanyl Citrate injection 100mcg/2ml >240min Note: Carmustine and Thiotepa have extremely low permeation times of 27.7 and 59.4 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa

The Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are blue color, powder free, nitrile gloves. The gloves are offered in six sizes: XS、S、M、L、XL、XXL, packed in a paper box.

The proposed gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978-05. The proposed device was modification from the legally marketed (existing) device "Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)"/K202356, manufactured by "KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED", same as the sponsor of this submission.

There are two modifications, one is to add a large model XXL, and the other is to add the "Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" indications for use than the legally marketed (existing) device. Testing has been conducted on the proposed device passed as per ASTM D6978-05, ASTM D6319-19, ASTM D5151-19, ASTMD 6124-06.

The materials and the manufacturing process technology are the same.

The provided document (a 510(k) summary for medical gloves) does not contain information about a study that proves a device meets acceptance criteria related to AI/ML or human reader performance. The document is for "Powder Free Nitrile Examination Gloves" and pertains to mechanical and material properties, as well as resistance to chemical permeation.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size used for a test set or data provenance for an AI/ML device.
3. Number of experts used to establish ground truth or their qualifications for an AI/ML device.
4. Adjudication method for an AI/ML device test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study for human readers with and without AI.
6. Standalone performance of an algorithm.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
8. Sample size for the training set of an AI/ML device.
9. How the ground truth for an AI/ML training set was established.

However, based on the document, I can present the acceptance criteria and performance for the glove device as non-clinical testing.

Acceptance Criteria and Study for Powder Free Nitrile Examination Gloves

This document describes the non-clinical testing performed on "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing of Gloves):

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

• The document does not specify the exact sample sizes (e.g., number of gloves tested for each attribute) for the physical and chemical resistance tests. It only states that tests were conducted according to the listed ASTM and ISO standards.
• Data Provenance: The testing was conducted to verify that the device meets design specifications and complies with international standards. The origin of the testing data is not explicitly stated beyond being "non-clinical tests."

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

• This is not applicable as the device is a medical glove, not an AI/ML diagnostic or prognostic tool. Ground truth is established by objective physical and chemical measurements following established standards, not by expert consensus or physician reads.

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

• Not applicable for this type of device testing.

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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

7. The type of ground truth used:

• For the physical properties (dimensions, watertightness, tensile strength, powder content), the ground truth is based on direct physical measurement and standard test methods outlined in ASTM standards.
• For chemical permeation (chemotherapy drugs and Fentanyl), the ground truth is established by analytical measurement of breakthrough time according to ASTM D6978-05.
• For biocompatibility (irritation, sensitization, cytotoxicity), the ground truth is established by biological assays according to ISO 10993 standards.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. The "training" for glove manufacturing relates to process control and material specifications, not a data-driven model.

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

• Not applicable as this is not an AI/ML device.

Ask a specific question about this device

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 select other drugs using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Blue), 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, 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, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and non-sterile.

The provided document describes the acceptance criteria and performance of "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs" (K240051).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Chemotherapy, Fentanyl Citrate & other drugs Permeation Comparison (Proposed Device K240051):

Warning: Do not use with Carmustine and Thiotepa due to "extremely low permeation times" (29.1 minutes and 78.3 minutes, respectively).

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

• The document primarily refers to standard ASTM and ISO test methodologies for device performance (e.g., ASTM D6319-19, ASTM D6978-05(2019), ISO 10993 series). These standards typically define the sample sizes required for each specific test to ensure statistical validity.
• Data Provenance: The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The tests were performed by Lingshi Hongruida Health Protection Technology Co., Ltd. located in China. The data is retrospective in the sense that the testing was performed and then submitted with the 510(k) application. Specific details on exact sample sizes (e.g., number of gloves tested for each characteristic) within each standard are not explicitly detailed in this summary for every test. However, the chemotherapy drug permeation testing likely involved multiple samples per drug as per ASTM D6978.

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 as the device is a physical medical device (examination glove) and the testing involved objective, quantitative, and standardized measurements according to established consensus standards (ASTM, ISO). There were no "experts" establishing a "ground truth" in the way they would for, say, image interpretation or clinical diagnosis. The ground truth for performance relied on the specified chemical and physical property measurements.

4. Adjudication method for the test set:

• This is not applicable. As mentioned above, the testing involved objective physical and chemical measurements governed by established standards, not subjective interpretations 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 an examination glove, not an AI-powered diagnostic tool or imaging software. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant.

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

• This is not applicable. This device is an examination glove and does not involve any algorithm or AI for standalone performance.

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

• The ground truth for this device's performance is based on objective measurements against established performance standards and chemical permeation resistance thresholds.
  • For physical properties (length, thickness, tensile strength, elongation, watertightness, powder content): The ground truth is the quantitative measurement compared against the specified ASTM standard values.
  • For chemical permeation (chemotherapy drugs, Fentanyl Citrate): The ground truth is the experimentally determined Minimum Breakthrough Detection Time (BDT) in minutes, measured according to ASTM D6978-05(2019).
  • For biocompatibility (irritation, sensitization, cytotoxicity, acute systemic toxicity): The ground truth is the experimental findings and conclusions derived from tests conducted under ISO 10993 series standards.

8. The sample size for the training set:

• This is not applicable. This device is a physical product, not a machine learning model, so there is no training set in the context of AI/ML.

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

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

Ask a specific question about this device

The glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, gloves were tested for use with Chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978.

Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, 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 provided document describes the acceptance criteria and results of non-clinical testing for "Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate" (K240072). This is a physical medical device (gloves), not an AI/ML powered device. Therefore, questions related to AI/ML specific criteria (such as effect size of human readers with AI assistance, sample size for training sets, number of experts for ground truth, adjudication methods) are not applicable.

Here's the relevant information from the document:

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

Breakthrough Detection Time (BDT) for Chemotherapy Drugs and Fentanyl Citrate:

Please refer to the tables provided in pages 3, 4, 7, and 8 of the document for the detailed BDT for each specific chemotherapy drug and Fentanyl Citrate for both Blue and Purple-Blue gloves. The general acceptance criterion implied is that the gloves provide a certain level of protection (BDT), and the performance reports these measured BDTs. Notably, for Carmustine and Thiotepa, the BDTs are explicitly called out as "extremely low permeation times" with a warning not to use them with these drugs.

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 specific non-clinical test (e.g., number of gloves tested for physical dimensions, chemotherapy permeation, etc.). However, these tests are generally conducted by manufacturers according to standardized protocols (e.g., ASTM standards) which define the required sample sizes for each test. The provenance specific to the data (e.g., country of origin, retrospective/prospective) is not detailed for these non-clinical bench tests. These are laboratory tests on the product itself.

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 submission (nitrile examination gloves) and not an AI/ML-powered device that would require expert-established ground truth from medical imaging or similar data. The acceptance criteria are based on defined physical and chemical properties measured through standardized bench tests.

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

Not applicable. Adjudication methods are typically associated with human review of data, especially in clinical or AI/ML studies, to establish ground truth. This document pertains to non-clinical bench testing of a physical product.

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 an AI/ML device, and no MRMC study was conducted.

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

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

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

The "ground truth" for this device is established through performance against recognized industry standards (e.g., ASTM D6319-19, ASTM D6978-05 (2019), ISO 10993 series). These standards define objective, measurable physical, chemical, and biological properties of the gloves. For example, breakthrough detection time for chemotherapy drugs is a direct measurement based on established laboratory procedures.

8. The sample size for the training set

Not applicable. This is a physical device; there is no "training set" in the context of AI/ML.

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

Not applicable. There is no training set for this physical device.

Ask a specific question about this device

The Powder-Free Nitrile 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.

Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)

The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for "Powder Free Nitrile Examination Gloves." These documents do not contain information related to software or AI-powered medical devices. Therefore, I cannot extract details about acceptance criteria or supporting studies for such a device.

The information you've requested (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is typically found in documentation for AI/Software as a Medical Device (SaMD) products, reflecting their performance evaluation.

This submission is for a Class I medical device (non-powdered patient examination glove), which is a physical product and does not involve AI or algorithms requiring the type of performance study details you've outlined.

Ask a specific question about this device

Sterile Powder Free Nittile Examination Gloves (Blue, Black and White Colors) is a disposable device intended for medical purposed that is worn on the examiner's hand to prevent contamination between patient and examiner.

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)

The provided text is an FDA 510(k) clearance letter for "Sterile Powder Free Nitrile Examination Gloves." This document does not contain information about acceptance criteria or a study proving that a device (in the context of an AI/software medical device) meets acceptance criteria.

The information you've requested typically applies to AI/ML (Artificial Intelligence/Machine Learning) or diagnostic medical devices that require performance evaluation against specific metrics (e.g., sensitivity, specificity, AUC). General medical devices like examination gloves are cleared based on substantial equivalence to predicate devices and meeting established performance standards (e.g., standards for tensile strength, barrier integrity, biocompatibility, sterility) through laboratory testing, not through clinical or reader studies that involve humans interacting with an AI or interpreting medical images.

Therefore, I cannot fulfill your request using the provided text. The document is strictly about the regulatory clearance of a physical medical device (gloves) and does not describe the kind of performance study you are asking about.

Ask a specific question about this device

The glove is 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 and fentanyl citrate in accordance with ASTM D6978.

The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs and fentanyl citrate claims. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and sterile. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for permeability to chemotherapy drugs and fentanyl citrate per ASTM D6978-05(2019).

The document provided is a 510(k) Premarket Notification from the FDA for "Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically by adding a claim for fentanyl citrate permeation. It performs non-clinical testing to support this claim, rather than a study involving AI or human readers for diagnostic purposes.

Therefore, many of the requested details regarding AI device acceptance criteria, human reader studies, and AI-specific ground truth establishment are not applicable to this submission. This is a clearance for a physical medical device (gloves), not a diagnostic AI/ML device.

However, I can extract the relevant information regarding the device's acceptance criteria and the non-clinical study conducted to prove it meets those criteria.

Acceptance Criteria and Study for Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

This medical device is a physical product (examination gloves), not an AI/ML diagnostic tool. The "acceptance criteria" here refer to the physical and chemical performance standards for the gloves, and the "study" refers to non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the re-submitted device (K232039) are based on relevant ASTM and ISO standards, and for chemotherapy and opioid drug permeation, specific minimum breakthrough times (BDT). The reported device performance indicates that the gloves passed all these criteria.

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

The document does not explicitly state the exact sample sizes used for each physical or chemical test. However, for tests like "Freedom from holes," it refers to AQL (Acceptable Quality Level) 2.5, which implies a sampling plan according to ASTM D5151-19. Similarly, other ASTM and ISO standards followed for physical properties and biocompatibility would specify sample sizes.

The data for these tests would be generated prospectively as part of product development and quality control for the submission. The country of origin for the data generation is implied to be China, given the manufacturer's location.

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

This concept is not applicable here. Ground truth in the context of this submission refers to the established standards and methodologies of the ASTM and ISO tests (e.g., how to measure tensile strength, how to test for permeation). These are standardized laboratory tests, not subjective expert interpretations of images or clinical outcomes. The "experts" are the laboratory personnel who perform these tests according to the published standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests have predefined, objective measurement protocols.

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 a physical medical device (gloves), not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. There is no algorithm or AI component in this device. Performance is measured directly through bench testing.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective, standardized laboratory measurements against predefined performance specifications stated in ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. Specifically:

• Physical Properties: Measured values (e.g., length, width, thickness, tensile strength, elongation) are compared directly against minimum/maximum thresholds defined in ASTM D6319-19 and ASTM D412-16.
• Freedom from holes: Determined by water leak testing according to ASTM D5151-19, with acceptance based on AQL 2.5.
• Powder Residue: Quantified according to ASTM D6124-06 (2017) against a maximum limit.
• Chemical Permeation: Breakthrough Time (BDT) is measured for specific chemotherapy drugs and fentanyl citrate according to ASTM D6978-05 (2019) and compared against specified minimum times.
• Biocompatibility: Assessed through in-vitro/in-vivo tests for irritation, sensitization (ISO 10993-10:2010), and acute systemic toxicity (ISO 10993-11:2017) to ensure no adverse biological reactions.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable, as there is no training set for an AI/ML algorithm.

Ask a specific question about this device

The Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs and Fentary) 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 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes.

The Powder Free Nitrile Examination Gloves, White, Test For Use With Chemotherapy Drugs and Fentanyl 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 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

The Powder Free Nittile Examination Gloves, Black,Test For Use With Chemotherapy Drugs and Fentary 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 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

Not Found

This document is a 510(k) premarket notification for disposable examination gloves, not an AI/ML device. Therefore, the requested information (acceptance criteria for an AI device, sample sizes for training/test sets, expert qualifications, etc.) is not applicable here.

However, I can extract the performance data of the gloves with respect to chemotherapy drug permeation, which serves as a kind of "acceptance criteria" and the "study" that proves the device meets it for this particular medical device.

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

The acceptance criterion for these gloves is their resistance to permeation by specific chemotherapy drugs and Fentanyl. The "performance" is the measured Breakthrough Detection Time (in minutes) when tested according to ASTM D6978-05 (2019). A higher breakthrough time indicates better resistance.

Powder Free Nitrile Examination Gloves (Blue)

Powder Free Nitrile Examination Gloves (White)

Powder Free Nitrile Examination Gloves (Black)

Note: The document explicitly states "Warning: Don't use with either Carmustine or Thiotepa" for all glove types, indicating that for these specific drugs, the breakthrough times (e.g., 11.3 - 43.3 minutes) are considered insufficient for safe use. This itself serves as an implicit "acceptance criterion" that for these two drugs no amount of permeation time would be considered acceptable for use. For the other drugs, ">240 minutes" is the reported performance, implying that the gloves withstand permeation for at least 4 hours, which is likely considered an acceptable duration for many clinical applications.

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

• Sample Size: The document does not specify the exact sample size (number of gloves or tests performed per drug). It simply states that the gloves "were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs". This standard details the testing methodology, which typically involves multiple replicate tests.
• Data Provenance: The testing was done in accordance with an international standard (ASTM D6978-05), suggesting a controlled laboratory environment. The manufacturer is Zibo Lanhua Medical Packaging Material Co., Ltd, based in Zibo, Shandong, China. The testing itself would be prospective in nature, as it's specifically conducted to evaluate the performance of these new glove formulations.

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 question is not applicable to this type of device. The "ground truth" here is objective physical measurement of chemical permeation, not subjective expert assessment of medical images or patient data. The "experts" involved would be laboratory technicians or chemists experienced in conducting ASTM D6978-05, not medical specialists.

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

Not applicable. Adjudication methods are typically used for subjective assessments (e.g., medical image interpretation) where multiple experts might disagree. Chemical permeation testing is a standardized, objective measurement.

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 an AI/ML device, nor does it involve human readers or comparative effectiveness studies in the context of diagnostic performance.

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)

The "ground truth" is objective, laboratory-measured chemical permeation data, obtained using a standardized testing method (ASTM D6978-05). This is a direct physical measurement.

8. The sample size for the training set

Not applicable. This is a manufactured product, not an AI/ML model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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Powder Free Nitrile Examination Gloves, Blue 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.
Powder Free Nitrile Examination Gloves, Black 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.
Powder Free Nitrile Examination Gloves, White 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.
The Powder Free Nitrile Examination Gloves, Violet Blue 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.
The Powder Free Latex Examination Gloves 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

This document is a 510(k) premarket notification decision letter from the FDA for examination gloves. It does not contain information about an AI/ML powered medical device, a clinical study with acceptance criteria and device performance. Therefore, I cannot extract the requested information.

The document is for "Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves," which are Class I devices (non-powered patient examination gloves) and do not involve AI. The FDA letter confirms the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for this type of device.

To provide the requested information, the input text would need to describe a medical device that uses AI/ML and include details about its performance studies.

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