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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Warning: Do not use with Carmustine and Thiotepa.

Note:
Please note that the following drugs have low permeation times:
(1) Carmustine - 22.5 minutes
(2) Thiotepa - 34.5 minutes.

The Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue are Class 1, Polymer Patient Examination Gloves and Chemotherapy Gloves.

The glove is made of Nitrile Butadiene Rubber. They are ambidextrous with beaded cuffs, fingertip texture and come in different sizes - Small, Medium, Large and Extra Large. 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(2023). The gloves are single use and provided non-sterile.

The provided FDA 510(k) clearance letter pertains to Nitrile Powder Free Examination Gloves, not a software-based medical device or AI system. Therefore, the questions regarding ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and data provenance are not applicable to this document.

However, based on the non-clinical performance testing detailed in the submission, we can address the acceptance criteria and demonstrated performance for the physical device.

Acceptance Criteria and Reported Device Performance for Nitrile Powder Free Examination Gloves K243694

The acceptance criteria for this medical device are based on various physical, chemical, and biological tests, primarily adhering to ASTM and ISO standards for examination gloves and their specific claims (chemotherapy and fentanyl resistance).

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document does not explicitly state the specific "sample size" for each individual test reported (e.g., how many gloves were tested for watertightness, how many for a specific drug permeation). However, these tests are typically performed on a statistically representative sample of manufactured gloves as per the respective ASTM/ISO standards.

• Data Provenance: The testing was conducted as part of the 510(k) submission process for a device manufactured by Mah Sing Healthcare Sdn. Bhd. in Malaysia. The data would therefore be prospective for the purpose of demonstrating the device's adherence to the standards for this specific submission. The data is generated from laboratory testing of the physical product.

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

Not applicable. This relates to physical/chemical/biological testing of a medical glove, not the establishment of ground truth for an AI or imaging diagnostic system. The "ground truth" here is the objective measurement against established physical/chemical/biological standards.

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1) are relevant to human review of diagnostic medical data, often for establishing a consensus "ground truth" when a definitive objective truth is unavailable (e.g., interpreting medical images). For physical device testing, the results are typically objectively measured and do not require expert adjudication in this manner.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. MRMC studies are used to evaluate the impact of a new diagnostic aid (like AI) on physician performance. This is for a physical medical device (examination gloves), not an AI system or diagnostic tool.

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

Not applicable. This question pertains to AI algorithm performance.

7. The type of ground truth used:

Objective Experimental Measurement and Compliance with Standardized Protocols. For each test (e.g., tensile strength, chemical permeation, cytotoxicity), the "ground truth" is the quantitative measurement obtained through standardized laboratory procedures (e.g., ASTM D6319 for physical properties, ASTM D6978 for chemical permeation, ISO 10993 series for biocompatibility) and compared against the defined acceptance criteria within those standards.

8. The sample size for the training set:

Not applicable. This question pertains to AI/machine learning models. Examination gloves do not have a "training set."

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

Not applicable. Again, this relates to AI/machine learning.

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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 (2019), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Powder Free Black Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs meets all the requirements of ASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR 880.6250. The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. These gloves are black in color and are powder free. The gloves are ambidextrous i.e., can be worn on right hand or left hand, single use disposable devices that come in five sizes (XS, S, M, L and XL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.

The provided document is a 510(k) premarket notification for Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs, and does not pertain to an AI/ML-enabled medical device. Therefore, the information requested about acceptance criteria and studies proving the device meets them in the context of an AI/ML device (e.g., sample size for test sets, data provenance, a number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not applicable to this document.

Instead, the document describes the acceptance criteria and performance of these medical gloves based on non-clinical bench testing to demonstrate substantial equivalence to a predicate device.

Here's the relevant information from the document regarding the glove's performance:

1. A table of acceptance criteria and the reported device performance (for the non-AI device: medical gloves):

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

• Sample Size for Testing: The document does not specify the exact sample sizes for each non-clinical test (e.g., how many gloves were tested for holes, tensile strength, or chemotherapy permeation for each batch/size). The results are presented as averages or ranges across sizes.
• Data Provenance: The tests were non-clinical bench tests performed by Mah Sing Healthcare Sdn. Bhd. (Malaysia), as indicated by the sender and manufacturer information. There is no mention of country of origin of data in the sense of patient data, as this device does not use patient data for its function. All tests are by standard methods (ASTM, ISO). The studies are inherently "prospective" in the sense that they are conducted specifically for this submission against defined standards.

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. Ground truth for these physical and chemical tests is established by the specified ASTM and ISO standard test methods, which are objective, reproducible procedures. No human experts are involved in establishing "ground truth" for the physical properties of a glove in the way they would for medical image interpretation.

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

• Not applicable. As these are objective bench tests, there is no need for human adjudication of results. The results are quantitative measurements or direct observations according to specified 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 not an AI/ML device.

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. The "standalone" performance here refers to the glove's physical and chemical properties and its resistance to chemotherapy drugs, which are measured directly.

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

• For this device, the "ground truth" is defined by the measurement outcomes according to internationally recognized standard test methods (ASTM and ISO) for physical properties (e.g., dimensions, tensile strength, freedom from holes, powder residue) and chemical resistance (chemotherapy drug permeation). For biocompatibility, it's defined by the in vivo animal study results according to ISO standards.

8. The sample size for the training set:

• Not applicable. There is no training set for a non-AI/ML device.

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

• Not applicable. There is no training set for a non-AI/ML device.

In summary, this document demonstrates the safety and effectiveness of medical gloves through adherence to established material and performance standards, not through AI/ML model validation studies.

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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 (2019), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drugs are as follows: Carmustine 3.3mg/ml, Cisplatin 1 mg/ml, Cyclophosphamide 20 mg/ml, Dacarbazine 10 mg/ml, Doxorubicin, HCl 2 mg/ml, Etoposide 20 mg/ml, Fluorouracil 50 mg/ml, Methotrexate 25 mg/ml, Mitomycin 0.5 mg/ml, Oxaliplatin 5 mg/ml, Paclitaxel 6 mg/ml, Thiotepa 10 mg/ml, Vincristine 1 mg/ml. Test Fentanyl Citrate are as follows: Fentanyl Citrate Injection 100mcg/2ml. Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have low permeation times: (1)Carmustine - 14.1 minutes (2)Thiotepa - 57.2 minutes.

Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR 880.6250. Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs are Class I patient examination gloves bear the product code Nitrile - LZA, LZC, OPJ and QDO (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. These gloves are blue in color and are powder free. The gloves are ambidextrous i.e., can be worn on right hand or left hand, single use disposable devices that come in five sizes (XS, S, M, L and XL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.

The provided document is a 510(k) summary for Nitrile Powder Free Blue Patient Examination Gloves. It details non-clinical testing to demonstrate the device meets acceptance criteria. No information regarding clinical effectiveness studies (such as MRMC studies or standalone algorithm performance for AI devices) is present, as this is not an AI/ML device.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for holes, number of material samples for tensile strength). However, the tests are conducted in accordance with the specified ASTM and ISO standards, which typically include defined sampling plans.

• Data Provenance: The origin of the data is from non-clinical laboratory testing performed by "Mah Sing Healthcare Sdn Bhd" or their contracted laboratories, as part of the 510(k) submission process. The submission is from Malaysia. This is prospective data generated for regulatory submission.

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

This information is not applicable as the device is a physical medical glove and the testing involves objective measurement against pre-defined physical, chemical, and biological standards, not interpretation by human experts or AI algorithms. Ground truth is established by the test procedures and acceptance criteria defined in the ASTM and ISO standards.

4. Adjudication Method for the Test Set:

This is not applicable. As stated above, the device performance is evaluated against objective standards, not through adjudication of expert interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This is not applicable. The device is a physical medical glove. The submission does not involve Artificial Intelligence (AI) or Machine Learning (ML) components, nor does it relate to diagnostic image interpretation where MRMC studies would typically be conducted.

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

This is not applicable. The device is a physical medical glove and does not involve an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these tests is based on defined performance specifications and measurement methodologies established by widely recognized consensus standards such as ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). For example:

• Physical dimensions: Measured against specified millimeter ranges.
• Tensile strength and elongation: Measured against minimum MPa and percentage values.
• Freedom from holes: Assessed against an Acceptable Quality Limit (AQL) per ASTM D5151-19.
• Chemotherapy drug permeation: Measured as breakthrough detection time in minutes per ASTM D6978-05.
• Biocompatibility: Assessed based on observable reactions in animal models according to ISO 10993 series and reported as "Passed" or "Not an irritant/sensitizer/systemic toxin."

8. The Sample Size for the Training Set:

This is not applicable. There is no "training set" as this device is not an AI/ML product. The manufacturing process is controlled and monitored, but there isn't a data-driven training phase for the device itself.

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

This is not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth established for one. The "ground truth" for glove manufacturing is established through quality control and adherence to standardized manufacturing practices and raw material specifications.

Ask a specific question about this device

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

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 (2019), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Chemotherapy Drugs Permeation
The following chemicals have been tested with these gloves.

Test Chemotherapy Drugs Concentration Breakthrough Detection Time in minutes *Carmustine 3.3mg/ml 24.8 Cisplatin 1 mg/ml >240 Cyclophosphamide 20 mg/ml >240 Dacarbazine 10 mg/ml >240 Doxorubicin, HCl 2 mg/ml >240 Etoposide 20 mg/ml >240 Fluorouracil 50 mg/ml >240 Methotrexate 25 mg/ml >240 Mitomycin C 0.5 mg/ml >240 Oxaliplatin 5 mg/ml >240 Paclitaxel 6 mg/ml >240 *Thiotepa 10 mg/ml 38.4 Vincristine 1 mg/ml >240

Warning- Not for use with Carmustine and Thiotepa.

Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs meets all the requirements of ASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR 880.6250.

Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs are Class I patient examination gloves bear the product code Nitrile – LZA (21CFR880.6250).

The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. These gloves are blue in color and are powder free. The gloves are ambidextrous i.e., can be worn on right hand or left hand, single use disposable devices that come in four sizes (S, M, L and XL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.

The provided document is a 510(k) Premarket Notification for "Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs". This document outlines the acceptance criteria and performance data for a medical device that is a physical commodity, not an AI/ML powered device. As such, information regarding AI/ML specific criteria like human-in-the-loop performance, effect size of human readers with AI assistance, standalone algorithm performance, number of experts for ground truth, or training set details are not applicable and not present in the document.

The acceptance criteria and reported device performance are based on recognized ASTM and ISO standards for medical gloves.

Here's the information extracted from the provided text, structured according to your request where applicable for a non-AI/ML device:

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

2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for each characteristic) or the detailed data provenance beyond adherence to international standards like ASTM and ISO. Given the nature of product testing for medical gloves, it is implied that appropriate sample sizes were used as prescribed by the respective ASTM and ISO standards. The tests are non-clinical (bench tests and biocompatibility tests). There is no explicit mention of data provenance in terms of country of origin or retrospective/prospective data collection for these 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 "ground truth" for physical properties and chemical permeation of medical gloves is established by the specified ASTM and ISO standards and their defined methodologies, not by expert consensus on specific samples in the same way an AI model's output would be adjudicated. The tests are objective measurements against defined criteria.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are objective measurements according to established standards. There is no human adjudication process described for these types of tests.

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.

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 consensus, pathology, outcomes data, etc)
The "ground truth" is defined by the technical specifications and methodologies outlined in the referenced ASTM standards (e.g., ASTM D6319-19 for physical properties, ASTM D6978-05 (2019) for chemotherapy drug permeation, ASTM D6124-06 for residual powder, ASTM D5151-19 for freedom from holes) and ISO standards (e.g., ISO 10993-10 and ISO 10993-11 for biocompatibility). These standards provide objective measurement criteria and test protocols.

8. The sample size for the training set
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

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

Nitrile Powder Free Blue Examination Gloves, Non-Sterile are Class I patient examination gloves bearing the product code Nitrile – LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. These gloves are blue in color and are powder free. The gloves are ambidextrous single use disposable devices that come in four sizes (S, M, L and XL).

The provided text describes the acceptance criteria and the results of a study for the "Nitrile Powder Free Blue Examination Gloves, Non-Sterile". Here's the information broken down as requested:

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

2. Sample size 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 specific sample sizes for each test. Instead, it refers to standards like ASTM and ISO, which would define the required sample sizes for such tests. For instance, for "Freedom of Holes," it refers to "AQL 1.5 with G1," which implies a sampling plan defined by ASTM D5151-19.

The data provenance is from Mah Sing Healthcare Sdn Bhd, located in Kuala Lumpur, Malaysia. The tests are non-clinical bench tests and biocompatibility tests conducted to support a premarket notification (510(k)). These are typically prospective tests performed specifically for the submission.

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 information is not applicable. The device is a medical glove, and the tests relate to its physical properties, chemical properties (residual powder), and biocompatibility, as measured by standard laboratory methods. There is no mention of human expert assessment or ground truth establishment in the context of medical image analysis or similar diagnostic tasks.

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

This information is not applicable. Adjudication methods are typically relevant in clinical studies or studies involving human interpretation of data where disagreements need to be resolved. The tests performed are laboratory-based and follow standardized testing 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

This information is not applicable. MRMC studies and AI assistance effectiveness are relevant for AI/ML-enabled diagnostic devices. The device in question is a medical glove, not an AI diagnostic tool.

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

This information is not applicable. The device is a medical glove and does not involve any algorithms or AI.

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

The "ground truth" for the tests performed is based on:

• Standardized measurement techniques and physical limits defined by international standards (ASTM D6124-06, ASTM D5151-19, ASTM D6319-19).
• Biological and chemical assays for biocompatibility (ISO 10993-10, ISO 10993-5, ISO 10993-11) where the "truth" is whether the material elicits a specific biological response (e.g., irritation, sensitization, cytotoxicity, systemic toxicity) above a defined threshold.

8. The sample size for the training set

This information is not applicable. There is no training set as the device is a physical product (medical glove) and not an AI/ML system.

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

This information is not applicable, as there is no training set.

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