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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.

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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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

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 primarily discusses non-clinical physical and biocompatibility testing. It cites compliance with ASTM and ISO standards for these tests. For these types of tests, specific sample sizes beyond what the standards prescribe are usually not detailed in the summary. For example, ASTM D6319-19 and ASTM D5151-19 would define the sampling plans. The document mentions "Three Lot" for the residual powder test, suggesting at least three batches were sampled.

The data provenance is from the manufacturer, Shandong YINGHONG Medical Products Co., Ltd., which is located in Qingzhou, Shandong, China. The studies are prospective as they are conducted for the specific purpose of device submission and evaluation against 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)

This information is not applicable as the device is a patient examination glove and the tests performed are physical and biocompatibility evaluations against established industry standards (ASTM, ISO). These do not involve human interpretation or expert-established ground truth in the way medical imaging or diagnostics might. The "ground truth" is defined by the objective measurement specifications of the standards.

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

This information is not applicable for the same reasons as point 3. Physical and biocompatibility tests are objective and do not typically involve 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 information is not applicable. The device is an examination glove, not an AI-assisted 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 an examination glove, not an algorithm.

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

The "ground truth" for the performance evaluation of these gloves is based on established industry standards and regulatory specifications as outlined in ASTM D6319-19, ASTM D6124-06, ASTM D5151-19, ISO 10993-10, and ISO 10993-5. This is objective and measurable, rather than relying on expert consensus or pathology in a clinical diagnostic sense.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of physical and biocompatibility testing of a medical device like an examination glove. These tests are direct evaluations against performance criteria.

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

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

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The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

This document describes the performance testing for a medical device: "Nitrile Patient Examination Glove" (K222527). The tests demonstrate that the device meets established acceptance criteria, primarily through non-clinical performance testing.

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

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

• Freedom from Holes: 125 gloves were tested.
• Biocompatibility (Irritation, Sensitization, Cytotoxicity), Powder Content, Dimensions, Physical Properties: The document does not specify the exact sample size for each of these tests, but it indicates that tests were performed according to the referenced ASTM and ISO standards, which typically include specific sampling plans. For instance, ASTM D6319 for dimensions requires a certain number of gloves per lot for testing.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the submitter's address is in China and the nature of the device (examination gloves), it is likely that the testing was conducted by or on behalf of the manufacturer, presumably in adherence to international standards.

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

This document describes technical and biological performance testing for medical gloves, not an AI or imaging device that requires expert human interpretation for ground truth. Therefore, there were no "experts" in the sense of radiologists or clinicians establishing ground truth for diagnostic accuracy in a test set. The "ground truth" for these tests is defined by the objective measurements obtained through standardized laboratory procedures (e.g., tensile strength, dimensions, chemical analysis, in vitro/in vivo biocompatibility assays).

4. Adjudication method for the test set

Not applicable. As noted above, this device did not involve human interpretation or subjective assessment that would require an adjudication method. The test results are quantitative measurements against predefined criteria.

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/imaging device, therefore, 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/imaging device, therefore, no standalone algorithm performance testing was conducted.

7. The type of ground truth used

The ground truth used for these tests is based on:

• Physical Measurements: Objective measurements of dimensions (length, width, thickness), tensile strength, and elongation according to ASTM standards.
• Chemical Analysis: Quantitative measurement of residual powder content.
• Biological Assays: Standardized in vitro (cytotoxicity) and in vivo (irritation, sensitization on animals) biological tests using established protocols (ISO 10993 standards) where the "ground truth" is the observed biological response compared to predefined thresholds.
• Defect Detection: Water leakage test for freedom from holes.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no training set in the AI context. The manufacturing process for gloves is subject to quality control and batch testing, rather than an AI training and validation paradigm.

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

Not applicable, as there is no training set.

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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.

Ask a specific question about this device

The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

The provided text describes the acceptance criteria and performance of a Nitrile Patient Examination Glove, not an AI-powered medical device. Therefore, the questions related to AI device performance metrics, such as ground truth, expert consensus, MRMC studies, and training/test sets, are not applicable in this context.

This document is a 510(k) Premarket Notification for a Class I medical device (nitrile examination glove), which establishes substantial equivalence to a predicate device based on physical and performance characteristics, and biocompatibility.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established ASTM and ISO standards for medical gloves. The reported device performance is compared against these standards and the predicate device.

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

• Freedom from Holes (ASTM D5151-19): 125 gloves were tested.
• Other tests (Biocompatibility, Dimensions, Physical Properties, Powder Content): Specific sample sizes for each test are not explicitly stated in the provided text, but testing was conducted to meet the requirements of the referenced ASTM and ISO standards, which define appropriate sample sizes and methodologies.
• Data Provenance: Not specified in terms of country of origin for the test data. The manufacturer is Jiangxi Zhonghong Pulin Medical Products Co.,Ltd. in China. The data would be prospective, as it's generated specifically for this regulatory submission.

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 medical device (glove), not an AI diagnostic tool that requires expert interpretation of images or other data for ground truth establishment. The "ground truth" here is the physical and chemical properties of the glove measured against established engineering and biological standards.

4. Adjudication method for the test set

Not applicable for a medical glove. Testing relies on standardized methods and laboratory measurements, not human adjudication of results in the way AI model outputs are typically adjudicated.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

Not applicable. MRMC studies are used for diagnostic imaging devices/algorithms to assess how human reader performance is affected by AI assistance. This device is a physical examination glove.

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

Not applicable. There is no algorithm to assess.

7. The type of ground truth used

The "ground truth" for this device is based on:

• Standardized Test Methods: Adherence to established international and national standards (e.g., ISO 10993 for biocompatibility, ASTM D6319 for physical properties of gloves, ASTM D5151 for freedom from holes).
• Reference Materials/Controls: For biocompatibility tests, positive and negative controls would be used as part of the standard methodology (ISO 10993).
• Objective Measurements: Laboratory measurements of physical dimensions, tensile strength, elongation, powder content, and visual inspection for holes.

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 for the same reason as above.

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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:

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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Nitrile Patient Examination Gloves, Powder Free, are intended for medical purposes that are worn on the examiners' hands to prevent contamination between patient and examiner.

The Nitrile Patient Examination Gloves, Powder Free are non-sterile, single use only, disposable, and powder free examination gloves. The glove is made of synthetic nitrile latex compound. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D 6319 - Standard specification for Nitrile Examination Gloves for Medical Application.

This document is a 510(k) Premarket Notification for Nitrile Patient Examination Gloves, Powder Free. It demonstrates the substantial equivalence of the proposed device to a legally marketed predicate device (Primus Nitrile Examination Gloves, K143477).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Device: Nitrile Patient Examination Gloves, Powder Free (Lalan Rubbers (Pvt) Ltd)

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

The document specifies that non-clinical tests were conducted to verify that the proposed subject device met all design specifications. The sample sizes for each specific test (e.g., number of gloves for physical testing, number of samples for biocompatibility) are not explicitly provided in this summary document. However, the tests are performed according to recognized international standards (ASTM and ISO), which typically specify appropriate sample sizes and methodologies.

The "data provenance" (country of origin, retrospective/prospective) is not detailed for the test samples, but the tests were performed by Lalan Rubbers (Pvt) Ltd in Sri Lanka, which is the manufacturer. The tests are prospective in nature, as they involve testing newly manufactured devices against established standards.

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

This device (Nitrile Patient Examination Gloves) does not involve expert interpretation or clinical diagnosis that would require human "ground truth" establishment in the typical sense of AI/clinical decision support systems. The "ground truth" here is objective measurement against established physical and chemical standards (ASTM D6319, ISO 10993 series). Therefore, there were no "experts" establishing a subjective ground truth for a test set in this context. The acceptance criteria are quantitative and based on published standards.

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

Not applicable. As noted above, the "ground truth" is objective measurement against established physical and chemical standards. There is no subjective interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical glove, not an AI-assisted diagnostic or clinical decision support system that involves human readers interpreting cases.

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

Not applicable. This is not an algorithm or AI device. The tests performed are for the physical, chemical, and biological properties of the glove itself.

7. The type of ground truth used

The ground truth used for this device's performance evaluation against acceptance criteria is objective measurement against recognized international standards and specifications. Specifically:

• Physical and Dimensional Properties: ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• Freedom from holes: ASTM D6319 and ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
• Powder Residual: ASTM D6319 and ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
• Biocompatibility: ISO 10993-10, ISO 10993-23, ISO 10993-11, ISO 10993-5 (Biological evaluation of medical devices for irritation, sensitization, systemic toxicity, and cytotoxicity)
• Shelf Life: EN 455-4:2009 (Medical gloves for single use Part 4: Requirements and testing for shelf life determination)

8. The sample size for the training set

Not applicable. This product is not an AI/machine learning model, so there is no concept of a "training set" in this context. The design and manufacturing process for the gloves are developed based on general engineering and material science principles, and then verified through the non-clinical tests mentioned.

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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The blue colored nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination 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., 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 5.0 mg/ml >240 min., Docetaxel 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., 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., Mitromycin C. 0.5 mg/ml >240, Mitoxantrone 2.0 mg/ml >240 min., Paclitaxel (Taxol) 6.0 mg/ml >240 min., Thiotepa 10.0 mg/ml 13.9 min., Vincristine Sulfate 1.0 mg/ml >240 min. Warning: Do not use with Carmustine and Thiotepa.

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 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: Carmustine (BCNU) 3.3 mg/ml 65.3 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., Methotrexate 25 mg/ml >240 min., Paclitaxel (Taxol) 6.0 mg/ml >240 min., Thiotepa 10.0 mg/ml 58.3 min. Warning: Do not use with Carmustine and Thiotepa.

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 Black Colored were tested for use with Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Fentanyl Citrate 100mcg/2ml >240 minutes.

Power-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, x-small (6.5"), small (7"), medium (8"), large (8.5"), X-large (9"), XXL (9.5"). Three colors are available for all size, includes blue, blue violet and black. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).

The provided document describes the acceptance criteria and study results for "Nitrile Patient Examination Gloves" (various colors) tested for use with chemotherapy drugs or Fentanyl Citrate. This is a medical device, and the evaluation is based on non-clinical performance standards rather than an AI/ML algorithm.

Therefore, many of the requested fields related to AI/ML studies (sample size for test set, data provenance, number of experts, adjudication method, MRMC comparative effectiveness, standalone performance, ground truth for training set, training set size) are not applicable to this submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test, but standard ASTM and ISO methods generally specify sample sizes. For example, AQL 2.5 for "freedom from holes" implies a sampling plan. Since these are performance tests on manufactured goods, the "test set" would be a batch or set of gloves sampled from production.
• Data Provenance: The document does not specify a country of origin for the testing data. The studies are described as "Non clinical tests" performed according to established international standards (ASTM, ISO). They are prospective in the sense that they are performed on the device to be marketed.

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 these tests is defined by objective physical and chemical measurements according to standardized protocols (ASTM, ISO), not expert interpretation.

4. Adjudication method for the test set

• Not applicable, as the evaluation is based on objective measurements against defined standards.

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 submission for physical medical gloves, not an AI/ML-driven device.

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

• Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven device.

7. The type of ground truth used

• The "ground truth" for these tests is the direct measurement of physical properties (e.g., dimensions, tensile strength, elongation), chemical properties (e.g., residual powder content), and barrier properties (permeation breakthrough time for chemotherapy drugs and Fentanyl Citrate) against established, objective industry standards (ASTM, ISO). For biocompatibility, it's the observed biological response to the glove material under controlled test conditions.

8. The sample size for the training set

• Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven device.

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

• Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven device.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable 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 colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in six sizes: XS, S, M, L, XL, XXL. The subject device is non-sterile.

This document describes the safety and performance of Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) as submitted for FDA 510(k) clearance (K213048). The study focuses exclusively on comprehensive bench testing and biocompatibility assessments, demonstrating the device's adherence to established standards for medical gloves, particularly regarding chemotherapy drug permeation.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific number of units (gloves) for each test, but it does refer to meeting ASTM standards, which would imply a scientifically sound sampling methodology.
For the Watertightness Test, the results state "0/125/Pass," indicating a sample size of 125 units was tested for holes.
The data provenance is based on non-clinical laboratory testing (bench testing) performed by or for Huayuan Medical Technology (Shangqiu) Co., Ltd. The specific location of testing is not detailed beyond the company's address in Shangqiu City, Henan Province, China. The data would be considered prospective for the purposes of this 510(k) submission, as these tests were conducted to demonstrate compliance for the specific device.

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

Not applicable. This submission relies on objective, standardized bench tests (e.g., ASTM, ISO standards) to establish performance. The "ground truth" is defined by the technical specifications and criteria outlined in these industry-recognized standards, rather than expert consensus on subjective data (like image interpretation in AI/clinical studies). No human experts were used to establish ground truth in the context of clinical/radiological assessment. The experts involved would be laboratory technicians and engineers qualified to perform and interpret the specified physical, chemical, and biological tests according to the standards.

4. Adjudication Method for the Test Set

Not applicable. Since the study involves objective bench testing against pre-defined acceptance criteria from international standards (ASTM, ISO), no human adjudication of test results is typically required beyond standard quality control and verification procedures of the testing laboratory.

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

No. This K213048 submission is for Nitrile Patient Examination Gloves, which are a physical medical device, not a diagnostic imaging AI system. Therefore, an MRMC comparative effectiveness study, which is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, was not performed. The study focuses on the physical and chemical properties of the gloves.

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

Not applicable. This is not an AI-powered diagnostic device or software. The "performance" being assessed is the physical and chemical resistance of the gloves, which is inherently a standalone performance of the material and manufacturing process under controlled laboratory conditions.

7. The Type of Ground Truth Used

The "ground truth" for this device is established by objective laboratory measurements against pre-defined technical specifications and performance criteria set forth in internationally recognized standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ASTM D6978-05, ISO 10993-5, ISO 10993-10). For example, the ground truth for "tensile strength" is a measured force in MPa, which is then compared to an acceptance criterion (e.g., ≥14MPa). For chemotherapy drug permeation, the ground truth is the measured breakthrough time in minutes.

8. The Sample Size for the Training Set

Not applicable. This is a traditional medical device (gloves), not an AI/machine learning model. Therefore, there is no "training set." The manufacturing process for physical gloves does not involve machine learning training.

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

Not applicable, as there is no training set for a physical device like examination gloves.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable 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 colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in six sizes: XS, S, M, L, XL, XXL. The subject device is non-sterile.

The provided document is a 510(k) premarket notification for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs). It details the device's technical characteristics, intended use, and performance testing results to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The core performance evaluation for these gloves relates to their physical properties, freedom from holes, powder content, biocompatibility, and most importantly, resistance to permeation by chemotherapy drugs.

Note on Chemotherapy Permeation Acceptance Criteria: The document primarily presents these as reported values and compares them to the predicate device in Table 1 (pages 6-7). The acceptance criteria for these would implicitly be that the breakthrough times are considered sufficient for safe use, or comparable/better than the predicate for equivalent drugs, with a clear warning for drugs with low permeation times. The "Warning: Please do not use with Carmustine (BCNU) and ThioTepa" indicates that the low breakthrough times for these specific drugs are accepted with a cautionary label, rather than requiring an explicit "minimum time" acceptance criterion for regulatory clearance.

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

The document does not explicitly state the total sample size for all tests performed. However, it does provide a specific sample size for one critical test:

• Watertightness Test (ASTM D5151): 125 gloves were tested (indicated by "0/125/Pass").
• For other tests (e.g., physical dimensions, tensile strength, powder content, biocompatibility, chemotherapy permeation), the specific number of gloves or samples tested is not explicitly stated in the provided summary, although the ASTM standards themselves would specify statistical sampling plans.
• Data Provenance: The tests were conducted by the manufacturer, Yunnan Huazhiyuan Medical Technology Co., Ltd. The location is China. The studies are retrospective in the sense that they are conducted on manufactured devices to demonstrate compliance with standards for the 510(k) submission, rather than being part of a prospective clinical trial.

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

This section is not applicable to this type of device and submission. The "ground truth" for the performance of these medical gloves is established through adherence to recognized international and national standards (ASTM, ISO) for physical properties, chemical resistance, and biocompatibility, as measured by laboratory equipment and procedures, not by expert human interpretation or consensus. No human "experts" are interpreting images or clinical data for this non-diagnostic device.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly in imaging or diagnostic device evaluations where multiple readers interpret data and discrepancies need to be resolved. For laboratory bench testing against physical and chemical standards, there is no human interpretation needing adjudication.

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

This section is not applicable. MRMC studies are specific to diagnostic devices, especially those involving image interpretation by multiple human readers, to assess the impact of an AI algorithm on reader performance. This device is a medical glove, a Class I non-diagnostic device, and its performance is evaluated through bench testing against established standards, not human reader studies.

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

This section is not applicable. This device is not an algorithm or AI-based product. Its performance is entirely standalone in the sense that its physical and chemical properties are measured directly from the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based entirely on laboratory bench testing results measured against predefined acceptance criteria established by recognized international standards (ASTM and ISO).

• Physical properties: Measured dimensions, tensile strength, elongation.
• Freedom from holes: Tested using a water-tightness test.
• Powder content: Measured residual powder.
• Biocompatibility: In vitro cytotoxicity, irritation, and sensitization tests.
• Chemotherapy drug permeation: Measured breakthrough times using specific chemical assays as per ASTM D6978-05.

8. The Sample Size for the Training Set

This section is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for the device's manufacturing process would be based on quality control and manufacturing specifications, not a data training set.

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

This section is not applicable as it pertains to AI/ML devices.

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