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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.

Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. 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. The gloves are single use, disposable, and provided non-sterile.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The device in question is "Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K242533).

Non-Clinical Performance Data

Clinical Performance Data

Study Information

Due to the nature of the device (patient examination gloves) and the provided documentation, several sections of your request are not directly applicable or explicitly detailed. This document is a 510(k) summary for a Class I medical device, which typically relies more on performance testing against established standards and equivalence to predicates rather than complex clinical trials like those for novel therapeutic devices.

Here's what can be extracted from the document:

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

   • Permeation Tests (ASTM D6978-05): The document does not specify the exact sample size used for the permeation tests for each chemical. The standard ASTM D6978-05 typically outlines the number of replicates required (e.g., three specimens).
   • Biocompatibility Tests (ISO 10993 series): Similarly, the sample sizes for these tests are not explicitly stated in the summary but would be specified by the respective ISO standards.
   • Clinical Test (Modified DRAIZE-95 Test): A 305-subject study was completed. The country of origin and whether it was retrospective or prospective is not specified, but such a test is typically prospective to evaluate a new or modified device.
   • Data Provenance: The document generally refers to testing "under the conditions of this study," without specifying the country of origin for non-clinical tests. The manufacturer is based in China.

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

   • For the non-clinical tests (physical properties, chemical permeation, biocompatibility), the "ground truth" is established by the standardized methods themselves (ASTM and ISO standards) and objective measurements by qualified laboratory personnel. The number of "experts" and their specific qualifications beyond standard lab certifications are not typically detailed in these summaries.
   • For the clinical test on dermatitis potential, the "ground truth" is derived from the subjects' reactions as evaluated by the study investigators. The qualifications of these investigators are not provided.

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

   • For the non-clinical tests, adjudication methods like 2+1 or 3+1 are not applicable. Results are based on objective measurements against defined criteria.
   • For the clinical test (Modified DRAIZE-95), the document does not specify an adjudication method. Clinical studies of this nature usually involve clinical investigators observing and documenting reactions, and a statistical analysis of the aggregate results.

4. 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 physical product (gloves), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

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

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

   • Physical and Chemical Tests: The ground truth is based on the objective measurements of the glove's properties (dimensions, strength, elongation, watertightness, powder residue) and breakthrough detection times for chemicals, all conducted according to recognized ASTM and ISO standards.
   • Biocompatibility Tests: Ground truth is determined by the biological response observed in in vitro (cytotoxicity) or in vivo (irritation, sensitization, acute systemic toxicity) models as interpreted against the acceptance criteria of the ISO 10993 standards.
   • Dermatitis Potential Clinical Test: The ground truth is the observed clinical reactions of human subjects to the device, evaluated against criteria for allergic contact sensitization.

7. The sample size for the training set:

   • Not applicable. This pertains to an algorithm or machine learning model. This device is a physical product.

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

   • Not applicable. As above, this is for an algorithm or machine learning model.

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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 to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Tested chemotherapy drugs are as follows:

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 12.1 minutes and Thiotepa:10.1 minutes.

Warning: Do not use with Carmustine or Thiotepa

The Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate. Aka Synguard C+ Nitrile Exam Gloves are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. Chlorination is applied to the inner surface of the glove to make donning easy. Characteristic:

• Ambidextrous with beaded cuff and straight fingers
• Finger-textured,
• Blue colored
• Containing Hyaluronic Acid coating.
• Six (6) sizes extra-small, small, medium, large, extra-large and XXL.
• Tested against chemotherapy drugs and fentanyl citrate.

The gloves are designed to meets the specifications of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided document is a 510(k) summary for a medical device (nitrile patient examination gloves with hyaluronic acid) and details the performance testing against established standards.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

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

The document includes a "Technological Characteristics Comparison Table" (pages 7-9) that serves this purpose. It compares the applicant's device to a predicate device (K200671). The "Acceptance Criteria" column effectively outlines the criteria, and the "Anhui Intco Medical Products Co., Ltd. Nitrile Patient Examination Gloves..." column shows the reported device performance.

3. Doxorubicin Hydrochloride (2.0mg/), Breakthrough time: >240 min.
4. Etoposide (Toposar) (20.0mg/ml), Breakthrough time: >240 min.
5. Fluorouracil (50.0mg/ml), Breakthrough time:>240 min.
6. Methotrexate (25.0 mg/ml), Breakthrough time: >240 min.
7. Paclitaxel (Taxol) (6.0 mg/ml), Breakthrough time: >240 min.
8. Thiotepa, Breakthrough time: 10.1 min.
9. Vincristine Sulfate (1.0 mg/ml), Breakthrough time:>240 min.
10. Cisplatin (1.0 mg/ml), Breakthrough time:>240 min.
11. Dacarbazine (10 mg/ml), Breakthrough time:>240 min.
12. Mitomycin C (0.5 mg/ml), Breakthrough time:>240 min.
13. Fentanyl Citrate Injection (100 mcg/2ml), Breakthrough time:>240 min. | Similar |

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 in the non-clinical tests (e.g., how many gloves were tested for pinholes, how many animals were used for biocompatibility testing). However, it refers to industry standards like ASTM and ISO, which typically define appropriate sample sizes for such tests.

• Provenance: The tests were performed in accordance with international standards (ASTM, ISO). The manufacturing company is Anhui Intco Medical Products Co., Ltd. located in Anhui, China. The testing itself is presented as non-clinical testing to demonstrate performance against these standards. The testing format suggests a retrospective evaluation against pre-defined performance criteria.

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 as the document describes performance testing of physical characteristics of gloves against codified standards (ASTM, ISO), not an AI device or a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" here is the pass/fail criteria defined by the standards.

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

This is not applicable as the document describes performance testing of physical characteristics against codified standards. There is no subjective adjudication process for the test results.

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 medical glove, not an AI-assisted diagnostic tool.

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

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

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

The "ground truth" for the performance tests conducted (e.g., tensile strength, pinholes, chemical permeation, biocompatibility) is established by industry standards and test methods (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D6978-05, ISO 10993 series). These standards define the acceptable range or threshold for a given characteristic to be considered compliant.

8. The sample size for the training set:

This is not applicable. The device is a medical glove, not an AI model that requires a training set.

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

This is 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)

Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, 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, 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.

The provided document describes the acceptance criteria and performance of "Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." It is important to note that this is a 510(k) summary for a medical device (gloves), not an AI/algorithm-driven device. Therefore, many of the requested fields related to AI clinical studies, such as sample sizes for AI test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable.

The studies described are non-clinical performance tests for the gloves themselves, not an AI system.

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

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

Detailed Chemotherapy Drug Permeation and Fentanyl Citrate Comparison Claim (Subject device K232266 performance):

Warning: Do not use with Carmustine (22.8 minutes) and Thiotepa (46.9 minutes).

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 specify general "sample sizes" for the test set in terms of medical images or patient data. Instead, it refers to standardized testing methodologies for physical and chemical properties of gloves. For instance, ASTM D5151 for water leak test would involve a certain number of gloves per batch as per AQL (Acceptable Quality Limit) standards, but the specific quantity is not stated in this summary. The data provenance is generally implied to be from laboratory testing conforming to the cited ASTM and ISO standards. The country of origin of the device manufacturer is China. These are prospective tests performed on the manufactured product.

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 not an AI or diagnostic device that requires expert ground truth for interpretation of medical images or patient data. The "ground truth" for the device's performance is established by the specified pass/fail criteria of the ASTM and ISO standards for glove manufacturing and material properties. The tests are laboratory-based and measure physical/chemical attributes.

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

Not applicable. Adjudication methods are relevant for human interpretation of data, typically in diagnostic or screening studies, not for the physical and chemical testing of medical gloves.

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 device.

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

Not applicable. This is not an AI device.

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

The "ground truth" for this device is based on standardized test methods and predetermined acceptance criteria defined by international and national standards organizations such as ASTM and ISO. These standards dictate acceptable physical dimensions, mechanical properties, chemical permeation resistance, and biological safety (e.g., irritation, sensitization, systemic toxicity) for medical examination gloves. For instance, for chemotherapy drug permeation, the "ground truth" is the measured breakthrough detection time according to ASTM D6978-05(2019).

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. As this is not an AI device, there is no "training set" or ground truth established in that context.

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The Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is a nitrile patient examination glove. The design of proposed device addresses the standard specification requirements of ASTM D6319-19. The proposed device is non-sterile and powder free, with fern green, midnight black and sky blue three colors.

The document provided describes the acceptance criteria and the results of non-clinical performance testing for "Patient Examination Gloves" (nitrile gloves) in support of a 510(k) submission (K230777).

Here's an analysis of the provided information, focusing on the requested aspects.

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

Please note that for multiple colors of gloves (Fern Green, Blue Sky, Midnight Black), the results were consistently reported and are summarized below for brevity where they pass the criteria. Where specific values for each color are provided and vary, they are listed.

Acceptance Criteria and Reported Device Performance

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

The subject device in this 510(k) Notification is Nitrile Patient Examination Gloves, Powder Free, Pink Color. The subject device is a patient examination glove made from nitrile compound, pink color, powder free and non-sterile (Per 21 CFR 880.6250, class I). These gloves are pink in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL).

The provided text describes the acceptance criteria and the study results for the "Nitrile Patient Examination Gloves, Powder Free, Pink Color" manufactured by Shandong YINGHONG Medical Products Co., Ltd.

Here's the breakdown of the requested information:

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

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.

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.

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The nitrile examination glove is intended to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carboplatin, 10 mg/ml >240 min. Carmustine (BCNU), 3.3 mg/ml 27.5 min Cisplatin, 1.0 mg/ml >240 min Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min Doxorubicin HCI, 2.0 mg/ml >240 min Etoposide, 20.0 mg/ml >240 min Fluorouracil, 50.0 mg/ml >240 min Paclitaxel, 6.0 mg/ml >240 min Thio Tepa, 10.0 mg/ml 88.2 min

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 27.5 Minutes, Thio Tepa 10.0 mg/ml 88.2 Minutes.

Warning: Please do not use with Carmustine and Thio Tepa.

The proposed device (Mode: NG101) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, include XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge. This is a single-use, powder-free, non-sterile device.

The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019)

The document describes the non-clinical testing performed to demonstrate that the Nitrile Patient Examination Gloves (K221747) meet their acceptance criteria and are substantially equivalent to a predicate device (K211220).

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes for each specific test within the non-clinical testing. It generally refers to "Final finished product" as the tested sample. The data provenance is not specified, but it can be inferred that the testing was conducted by or on behalf of the manufacturer, Fitone Latex Products Co., Ltd. Guangdong, which is based in China. The nature of the tests (physical, chemical, and biocompatibility) suggests these were laboratory-based tests on manufactured product samples. The document does not indicate if the data is retrospective or prospective, though it is standard practice for such tests to be prospective assessments of newly manufactured products.

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 tests described are non-clinical, objective measurements against established ASTM and ISO standards for material properties and performance. There is no human interpretation or expert ground truth establishment for these types of tests (e.g., measuring glove dimensions, tensile strength, or chemical permeation).

4. Adjudication method for the test set:

This information is not applicable for the same reason as point 3. Adjudication methods are typically used in studies involving human interpretation or subjective assessments.

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. The submission is for a medical glove, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance comparison was conducted.

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

This information is not applicable as the device is not an algorithm or AI-based system.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests is based on established industry standards and specifications:

• ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D5151-19 (Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124-06(2017) (Test Method for Residual Powder on Medical Gloves)
• ASTM D573-04(2019) (Test Method for Rubber-Deterioration in an Air Oven)
• ISO 10993-5: 2009 (Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity)
• ISO 10993-10: 2010 (Biological Evaluation Of Medical Devices Part 10: Tests For Irritation And Skin Sensitization)
• ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs)

These standards define the acceptance criteria (e.g., minimum tensile strength, maximum residual powder, breakthrough times for chemotherapy drugs).

8. The sample size for the training set:

This information is not applicable as there is no training set for a medical glove. These are physical products tested against predetermined specifications.

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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The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The Nitrile Patient Examination Gloves Blue Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows:

Bleomycin Sulfate 15 mg/ml >240 min. Busulfan 6 mg/ml >240 min. Carboplatin 10 mg/ml >240 min. Carmustine (BCNU) 3.3 mg/ml 17.2 min. Cisplatin 1.0 mg/ml >240 min. Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. Cytarabine HCI 100 mg/ml >240 min. Dacarbazine (DTIC)10.0 mg/ml >240 min. Daunorubicin 5 mg/mL >240 min. Docetaxel 10.0 mg/ml >240 min Doxorubicin HCI 2.0 mg/ml >240 min. Epirubicin HCI 2.0 mg/ml >240 min. Etoposide (Toposar) 20.0 mg/ml >240 min. Fludarabine 25.0 mg/ml >240 min. Fluorouracil 50.0 mg/ml >240 min. Gemcitabine 38 mg/ml>240 min. Idarubicin 1 mg/ml >240 min. Ifosfamide 50.0 mg/ml >240 min. Irinotecan 20.0 mg/ml >240 min. Mechlorethamine HCI 1.0 mg/ml>240 min. Melphalan 5 mg/ml >240 min. Methotrexate 25 mg/ml >240 min. Mitromvcin C. 0.5 mg/ml >240 Mitoxantrone 2.0 mg/ml >240 min. Paclitaxel (Taxol) 6.0 mg/ml >240 min. Rituximab 10.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 13.9min. Trisenox 1.0 mg/ml >240 min. Vincristine Sulfate 1.0 mg/ml >240 min. Fentanyl Citrate 100mcg/2ml >240 minutes

Warning: Do not use with Carmustine and Thiotepa.

The Nitrile Patient Examination Gloves Blue Violet Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The tested chemotherapy drug are as follows: Bleomycin Sulfate 15 mg/ml >240 min. Busulfan 6 mg/ml >240 min. Carboplatin 10 mg/ml >240 min. Carmustine (BCNU) 3.3 mg/ml 65.3 min. Cisplatin 1.0 mg/ml >240 min. Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. Cytarabine HCI 100 mg/ml >240 min. Dacarbazine (DTIC)10.0 mg/ml >240 min. Daunorubicin 5 mg/mL >240 min. Docetaxel 10.0 mg/ml >240 min Doxorubicin HCI 2.0 mg/ml >240 min. Epirubicin HCl 2.0 mg/ml >240 min. Etoposide (Toposar) 20.0 mg/ml >240 min. Fludarabine 25.0 mg/ml >240 min. Fluorouracil 50.0 mg/ml >240 min. Gemcitabine 38 mg/ml>240 min. Idarubicin 1 mg/ml >240 min. Ifosfamide 50.0 mg/ml >240 min. Irinotecan 20.0 mg/ml >240 min. Mechlorethamine HCI 1.0 mg/ml>240 min. Melphalan 5 mg/ml >240 min. Methotrexate 25 mg/ml >240 min. Mitromvcin C. 0.5 mg/ml >240 Mitoxantrone 2.0 mg/ml >240 min. Paclitaxel (Taxol) 6.0 mg/ml >240 min. Rituximab 10.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 58.3min. Trisenox 1.0 mg/ml >240 min. Vincristine Sulfate 1.0 mg/ml >240 min. Fentanyl Citrate 100mcg/2ml >240 minutes

Warning: Do not use with Carmustine and Thiotepa.

The Nitrile Patient Examination Gloves Black Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The tested chemotherapy drug are as follows: Carmustine (BCNU) 3.3 mg/ml 49.2 min. Cisplatin 1.0 mq/ml >240 min. Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. Dacarbazine (DTIC)10.0 mg/ml >240 min. Doxorubicin HCI 2.0 mg/ml >240 min. Etoposide (Toposar) 20.0 mg/ml >240 min. Fluorouracil 50.0 mg/ml >240 min. Fentanyl Citrate 100mcg/2ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 87.1min.

Warning: Do not use with Carmustine and Thiotepa.

Powder-Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in six sizes, extra-small, medium, large, extralarge, extra-extra-large. Three colors are available for all size, includes blue, blue violet and black.

The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).

This document describes the premarket notification (510(k)) for Nitrile Patient Examination Gloves, with specific testing for chemotherapy drug permeation. Based on the provided text, the "device" is a physical product (gloves) and not an AI/software device, therefore many of the requested criteria (MRMC study, AI assistance, ground truth establishment, training set, etc.) are not applicable.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, based entirely on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Width:
Extra-Small: 70±10mm
Small: 80±10mm
Medium: 95±10mm
Large: 110±10mm
Extra-Large: 120±10mm
Extra-Extra-Large: ≥120mm

Thickness (mm):
Finger: ≥0.05
Palm: ≥0.08 | Pass |
| ASTM D6319 (Physical Properties) | Physical Properties (Tensile Strength & Elongation) | Before Aging:
Tensile Strength: ≥14MPa
Ultimate Elongation: ≥500%

After Aging:
Tensile Strength: ≥14MPa
Ultimate Elongation: ≥500% | Pass |
| ASTM D5151 | Freedom from pinholes | Meet the requirements of ASTM D5151 Test for AQL 2.5 | Pass |
| ASTM D6124 | Powder Residue | Meet the requirements of ASTM D6124 240 min.

• Busulfan 6 mg/ml: >240 min.
• Carboplatin 10 mg/ml: >240 min.
• Carmustine (BCNU) 3.3 mg/ml: 17.2 min.
• Cisplatin 1.0 mg/ml: >240 min.
• Cyclophosphamide (Cytoxan) 20.0 mg/ml: >240 min.
• Cytarabine HCI 100 mg/ml: >240 min.
• Dacarbazine (DTIC)10.0 mg/ml: >240 min.
• Daunorubicin 5 mg/mL: >240 min.
• Docetaxel 10.0 mg/ml: >240 min
• Doxorubicin HCI 2.0 mg/ml: >240 min.
• Epirubicin HCI 2.0 mg/ml: >240 min.
• Etoposide (Toposar) 20.0 mg/ml: >240 min.
• Fludarabine 25.0 mg/ml: >240 min.
• Fluorouracil 50.0 mg/ml: >240 min.
• Gemcitabine 38 mg/ml: >240 min.
• Idarubicin 1 mg/ml: >240 min.
• Ifosfamide 50.0 mg/ml: >240 min.
• Irinotecan 20.0 mg/ml: >240 min.
• Mechlorethamine HCI 1.0 mg/ml: >240 min.
• Melphalan 5 mg/ml: >240 min.
• Methotrexate 25 mg/ml: >240 min.
• Mitomycin C. 0.5 mg/ml: >240
• Mitoxantrone 2.0 mg/ml: >240 min.
• Paclitaxel (Taxol) 6.0 mg/ml: >240 min.
• Rituximab 10.0 mg/ml: >240 min.
• Thiotepa 10.0 mg/ml: 13.9 min.
• Trisenox 1.0 mg/ml: >240 min.
• Vincristine Sulfate 1.0 mg/ml: >240 min.
• Fentanyl Citrate 100mcg/2ml: >240 minutes
  Warning: Do not use with Carmustine and Thiotepa.

Nitrile Patient Examination Gloves Blue Violet (Tested Drugs & Permeation Time):

• Bleomycin Sulfate 15 mg/ml: >240 min.
• Busulfan 6 mg/ml: >240 min.
• Carboplatin 10 mg/ml: >240 min.
• Carmustine (BCNU) 3.3 mg/ml: 65.3 min.
• Cisplatin 1.0 mg/ml: >240 min.
• Cyclophosphamide (Cytoxan) 20.0 mg/ml: >240 min.
• Cytarabine HCI 100 mg/ml: >240 min.
• Dacarbazine (DTIC)10.0 mg/ml: >240 min.
• Daunorubicin 5 mg/mL: >240 min.
• Docetaxel 10.0 mg/ml: >240 min
• Doxorubicin HCI 2.0 mg/ml: >240 min.
• Epirubicin HCl 2.0 mg/ml: >240 min.
• Etoposide (Toposar) 20.0 mg/ml: >240 min.
• Fludarabine 25.0 mg/ml: >240 min.
• Fluorouracil 50.0 mg/ml: >240 min.
• Gemcitabine 38 mg/ml: >240 min.
• Idarubicin 1 mg/ml: >240 min.
• Ifosfamide 50.0 mg/ml: >240 min.
• Irinotecan 20.0 mg/ml: >240 min.
• Mechlorethamine HCI 1.0 mg/ml: >240 min.
• Melphalan 5 mg/ml: >240 min.
• Methotrexate 25 mg/ml: >240 min.
• Mitomycin C. 0.5 mg/ml: >240
• Mitoxantrone 2.0 mg/ml: >240 min.
• Paclitaxel (Taxol) 6.0 mg/ml: >240 min.
• Rituximab 10.0 mg/ml: >240 min.
• Thiotepa 10.0 mg/ml: 58.3 min.
• Trisenox 1.0 mg/ml: >240 min.
• Vincristine Sulfate 1.0 mg/ml: >240 min.
• Fentanyl Citrate 100mcg/2ml: >240 minutes
  Warning: Do not use with Carmustine and Thiotepa.

Nitrile Patient Examination Gloves Black (Tested Drugs & Permeation Time):

• Carmustine (BCNU) 3.3 mg/ml: 49.2 min.
• Cisplatin 1.0 mg/ml: >240 min.
• Cyclophosphamide (Cytoxan) 20.0 mg/ml: >240 min.
• Dacarbazine (DTIC)10.0 mg/ml: >240 min.
• Doxorubicin HCI 2.0 mg/ml: >240 min.
• Etoposide (Toposar) 20.0 mg/ml: >240 min.
• Fluorouracil 50.0 mg/ml: >240 min.
• Fentanyl Citrate 100mcg/2ml: >240 minutes
• Paclitaxel (Taxol) 6.0 mg/ml: >240 min.
• Thiotepa 10.0 mg/ml: 87.1 min.
  Warning: Do not use with Carmustine and Thiotepa. | The permeation resistance was tested and the break-through times for each listed chemotherapy drug are reported as the "Results" for each glove colored variation. The tables within the document (pages 8-10, and 12-14) explicitly list these times. The general acceptance criterion for these types of tests is generally that the glove provides a minimum specified protection time (e.g., >240 minutes for many drugs, unless a shorter warning is given), and these results are directly reported. The "Pass" in the summary table (page 18) indicates overall compliance with the standard for specific tests. |

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

• Sample Size: The document does not specify the exact sample size (number of gloves) used for each individual test (e.g., how many gloves were tested for permeation by each drug). It generally refers to "tests" being performed.
• Data Provenance: The tests were conducted according to established ASTM and ISO standards for medical devices. The manufacturer is "Guang Dong Kingfa Sci. & Tech.Co., Ltd." in China. The data itself is from laboratory testing, not from patient data. The studies are non-clinical (in-vitro, physical/chemical tests).

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

• Not Applicable. This is a physical device (medical gloves) and not an AI/software device that requires expert human interpretation or consensus for ground truth establishment. The "ground truth" here is the measured performance of the glove against established physical and chemical standards (e.g., tensile strength, pinhole presence, chemical permeation time).

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

• Not Applicable. As this is not an AI/software device involving human-in-the-loop decisions or human interpretive tasks, no adjudication method for ground truth was used.

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 device, not an AI/software system for medical image analysis or diagnosis.

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

• Not Applicable. This is a physical device, not an algorithm. The device's performance is standalone in that its properties (e.g., permeation resistance) are directly measured.

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

• The "ground truth" for these tests is defined by adherence to published international standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11, and particularly ASTM D6978-05 for chemotherapy drug permeation). For the chemotherapy drug permeation specifically, the ground truth is the experimentally determined breakthrough time of the specific chemicals through the glove material under controlled laboratory conditions, as specified by the standard.

8. The sample size for the training set:

• Not Applicable. This is a physical device; there is no 'training set' in the machine learning sense. The manufacturing process and quality control would involve internal testing, but this is not referred to as a "training set" in the context of typical AI/ML device submissions.

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

• Not Applicable. As there is no training set for an AI/ML model, this point does not apply.

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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 six sizes (XS, S, M, L, XL and XXL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.

The document describes the acceptance criteria and the results of non-clinical testing for the Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile (K221378).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes used for each specific non-clinical test. However, it implicitly indicates that various sizes of gloves (XS, S, M, L, XL, XXL) were tested for several parameters (e.g., residual powder, length, width, thickness, tensile strength, ultimate elongation), meaning multiple samples were drawn for each size.

• Data Provenance: The tests were performed by Tec Gloves Industry (M) Sdn. Bhd. for their "Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile". This suggests the data provenance is from the manufacturer's internal testing. The country of origin of the manufacturer is Malaysia. The data is prospective as it was generated to demonstrate compliance for this specific device.

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

Not applicable. The tests performed are non-clinical, objective measurements based on specified ASTM and ISO standards, not subjective expert evaluation of medical images or conditions.

4. Adjudication Method for the Test Set

Not applicable. This is not a human-in-the-loop study requiring adjudication of expert opinions. The performance criteria are defined by established international standards (ASTM, ISO).

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 510(k) submission for patient examination gloves, which are physical medical devices, not an AI/software device that would involve human readers or cases.

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

Not applicable. The device is a physical glove, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on predefined acceptance criteria specified by international standards (ASTM D6124-06, ASTM D5151-19, ASTM D6319-19, ISO 10993-10, ISO 10993-11). The results are quantitative measurements or qualitative observations (e.g., "not an irritant") against these established standard requirements. For example, for "Residual Powder Content," the ground truth is "Less than 2mg/glove."

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

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

Not applicable. As there is no training set for this device.

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