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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.

Ask a specific question about this device

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.

Ask a specific question about this device

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs 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.

Ask a specific question about this device

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

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

These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

This document describes the safety and efficacy of "Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K213408) by comparing its performance to a predicate device (K192954) and established ASTM standards. The study focuses on non-clinical testing, particularly the glove's resistance to permeation by chemotherapy drugs and fentanyl citrate.

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for this device are based on meeting or exceeding the minimum breakthrough detection times for various chemotherapy drugs and fentanyl citrate, as specified by ASTM D6978-05 (Reapproved 2019). Other criteria include physical properties, dimensions, watertight integrity, residual powder, and biocompatibility.

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

• Physical Properties (Tensile Strength, Elongation): Sample size not explicitly stated for individual tests, but implied to be sufficient for ASTM standards.
• Dimension: Sample size not explicitly stated.
• Water Tight: Sample size of 500 pieces (based on AQL level M for a batch of 500,001 or more).
• Residual Powder: Sample size of 5 pieces.
• Permeation by Chemotherapy Drugs and Fentanyl Citrate: Sample size not explicitly stated, but tests were performed per ASTM D6978-05.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity): Sample sizes for the animal testing are not explicitly reported in this summary, but the results indicate standard testing procedures were followed.
• Data Provenance: The standard testing was conducted by Meditech Gloves Sdn Bhd, located in Malaysia. The study is a non-clinical study assessing the device's characteristics against recognized standards. It is implicitly a prospective evaluation for regulatory submission.

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

This document describes non-clinical laboratory testing. There is no indication of human experts establishing "ground truth" for the test set in the way a clinical study would involve expert readers. The ground truth is defined by the objective measurement criteria within the ASTM and ISO standards used (e.g., specific permeation detection limits, physical property thresholds, AQL levels).

4. Adjudication Method for the Test Set:

Not applicable. This is a non-clinical device test where results are determined by objective measurements against established standard criteria, not by human interpretation requiring adjudication.

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

Not applicable. This device is a patient examination glove, and the study focuses on its material and barrier properties, not on diagnostic accuracy involving human readers. Therefore, an MRMC study was not performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a physical medical device (glove), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for this study is based on predefined technical specifications and validated test methodologies outlined in international standards such as:

• ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D6978-05 (Reapproved 2019) (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
• ASTM D412-16 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension)
• ASTM D3767-03(2020) (Standard Practice for Rubber—Measurement of Dimensions)
• ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124-06 (2017) (Standard Test Method for Residual Powder on Medical Gloves)
• ISO 10993-10:2010 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
• ISO 10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
• ISO 10993-11:2017 (E) (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)

The performance of the gloves is directly measured against the quantitative and qualitative acceptance criteria specified in these standards.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical product whose performance is evaluated through material and chemical barrier integrity tests.

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 powder free patient examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over the counter use.

Medcare Powder-Free Blue Nitrile Patient Examination Gloves 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 nitrile, powder- free, ambidextrous, and blue-colored with a beaded cuff. The proposed device is offered in the following sizes: S, M, L, XL.

Here's a breakdown of the acceptance criteria and study information for the Medcare Powder-Free Blue Nitrile Patient Examination Gloves (K211808) based on the provided text, formatted to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since the device is a Class I medical device (patient examination gloves), the studies described are non-clinical performance tests to demonstrate substantial equivalence to a predicate device, not typical clinical studies with human participants that would involve the following points you requested. Therefore, for most of the remaining points, the answer is "Not Applicable" or "Not Provided" in the context of this 510(k) submission.

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

• Sample size: Not explicitly stated for each individual test, but the ASTM and ISO standards for material testing typically specify sample sizes.
• Data provenance: Not explicitly stated whether retrospective or prospective. The manufacturer is Dongguan Grinvald Technology Co., Ltd. - China.

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

• Not Applicable. These are objective, quantitative material and biological tests performed according to standardized protocols (ASTM, ISO). "Ground truth" in the clinical sense with expert consensus is not relevant here. The "experts" would be the accredited laboratory personnel performing the tests according to the standard methods.

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

• None. Adjudication methods are typically used for subjective assessments or when there's disagreement among human readers in interpreting clinical data. These non-clinical tests have objective pass/fail 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 a non-clinical device (patient examination glove). AI assistance or human reader improvement studies are not relevant to its regulatory pathway.

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

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

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

• Objective, standardized test results. The "ground truth" is established by the specified acceptance criteria within each ASTM or ISO standard, which are quantitative thresholds for physical properties and defined biological responses.

8. The sample size for the training set

• Not Applicable. This device does not involve a training set in the machine learning context. The "training" for the device's manufacturing would be adherence to quality control procedures and standard operating procedures.

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

• Not Applicable. As above, no training set for an algorithm is involved.

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