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

The subject device is powder free nitrile examination gloves. The subject device is in blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for Disposable Nitrile Examination Gloves. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study findings based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Sizes:
  • ASTM D5151 (Watertightness): 125 samples (stated as "0/125/Pass")
  • ASTM D6319 (Dimensions), ASTM D6124 (Powder Content), ASTM D412 (Physical Properties): Specific sample sizes for each glove size (S, M, L, XL) are not explicitly stated, but the results are presented for each size.
  • Biocompatibility (ISO 10993-5, -10, -11): Not explicitly stated, but these typically involve a certain number of replicates and control groups for in vitro or in vivo tests.
• Data Provenance: The document implies that the testing was conducted by or for the manufacturer, Jiangxi Handspro Products Solutions CO., LTD. in China. The data is from non-clinical testing designed to evaluate the physical and biological characteristics of the device. It is prospective in the sense that these tests were conducted intentionally for this 510(k) submission.

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

This section is not applicable for this type of device and study. The "ground truth" for the non-clinical testing of medical gloves (like dimensions, physical properties, or biocompatibility) is established by adherence to recognized international and national standards (e.g., ASTM, ISO). There are no human experts "establishing ground truth" in the way a radiologist would for medical imaging. The standards themselves define the test methods and acceptance criteria.

4. Adjudication method for the test set

This is not applicable for non-clinical performance testing. Adjudication methods like "2+1" are relevant for clinical studies or expert review processes where subjective interpretations might differ. For objective measurements against established standards, the results are determined by the test execution itself.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or screening devices, not for disposable examination gloves.

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

No, a standalone algorithm performance study was not done. This device is not an AI algorithm.

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

The "ground truth" is defined by established international and national consensus standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10, ISO 10993-11). These standards specify the methods for measurement and the acceptable ranges for physical properties and biological responses.

8. The sample size for the training set

Not applicable. This device is a physical medical product (disposable gloves), not a machine learning or AI algorithm that requires a training set.

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

Not applicable. As stated above, this device does not utilize a training set.

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Cytotoxicity: The table on page 11 explicitly states "Under conditions of the study, device extract is cytotoxic." for ISO 10993-5. This appears to contradict the general conclusion that the device is "as safe, as effective." However, the predicate comparison table on page 8 indicates that the predicate device also stated "ISO 10993-5 Under conditions of the study, device extract is cytotoxic," and the subject device has a "/" for this criterion without a definitive pass/fail statement in that specific comparison table. In the non-clinical testing summary, it lists ISO 10993-5 as one of the standards conducted. If the device genuinely exhibited cytotoxicity, it would typically be a concern. Given the overall clearance, there might be further explanation or context not fully detailed in this summary (e.g., the level of cytotoxicity was deemed acceptable, or the "is cytotoxic" statement might be an error in the summary table on page 11, or the nature of the cytotoxicity and its relevance to direct patient contact for a glove was evaluated and deemed non-critical).

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

• Physical Dimensions (ASTM D6319): Not explicitly stated, but the results show ranges across sizes (S, M, L, XL).
• Watertightness Test (ASTM D5151): The results specify "0/125/Pass," indicating a sample size of 125 items (gloves) were tested, all passing (0 failures).
• Powder Content (ASTM D6124): Not explicitly stated.
• Physical Properties (ASTM D412): Not explicitly stated.
• Biocompatibility (ISO 10993-5, -10, -11): Not explicitly stated.
• Chemotherapy Drug Permeation (ASTM D6978-05): Not explicitly stated, however, the standard ASTM D6978 mandates three specimens be tested for each drug exposure for each material tested (so, 3 specimens per drug per color of glove). There are 12 drugs tested for 3 colors, so at least 3 x 12 x 3 = 108 specimens would have been tested as a minimum requirement for this standard.

The data provenance is from non-clinical bench testing conducted to relevant ASTM and ISO standards, indicating laboratory testing. The country of origin of the test data is not explicitly stated, but given the manufacturer is Jiangsu Bytech Medical Supplies Co.,Ltd. in China, it is likely the testing was performed either in China or by a certified lab contracted by the manufacturer. The data is reported retrospectively as part of the 510(k) submission.

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

This device is a physical product (gloves) and the tests conducted are bench-top performance tests and biocompatibility tests. Therefore, human experts are typically not used to establish a "ground truth" in the way they would for an AI diagnostic device (e.g., radiologists reviewing images). The ground truth is established by the methods and specifications defined in the referenced industry standards (ASTM, ISO). Laboratory technicians and chemists, qualified to perform these specific tests, would have conducted the studies.

4. Adjudication method for the test set:

Not applicable, as this involves objective laboratory measurements against established standards, not human 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 diagnostic or assistance tool. The evaluation focuses on its physical and chemical properties.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

The ground truth is based on:

• Standardized Test Methods: Specifications and methodologies outlined in ASTM (e.g., D6319, D5151, D6124, D412, D6978) and ISO standards (e.g., 10993-5, 10993-10, 10993-11).
• Objective Measurements: These standards define how properties like dimensions, watertightness, powder content, tensile strength, elongation, and drug permeation breakthrough times are measured objectively.
• Pre-defined Acceptance Criteria: The pass/fail criteria for these measurements are often specified within the standards or derived from regulatory guidance for the device type.

8. The sample size for the training set:

Not applicable. This is a physical device, not a machine learning model, so there is no training set in this context.

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

Not applicable. There is no training set.

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The Disposable Nitrile Examination Gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

This document describes the premarket notification for Disposable Nitrile Examination Gloves (K212833). Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Device Performance

Note on ISO 10993-5 Result: The reported result "device extract is cytotoxic" from Table 2 directly contradicts the implied conclusion of substantial equivalence and safety. Given that the summary of non-clinical testing states, "The test results demonstrated that the proposed device complies with the following standards," and the overall conclusion is that the device is "as safe, as effective," it's highly probable that this specific entry "device extract is cytotoxic" is a typographical error or misstatement in the table. The comparison table with the predicate device (K203593) also indicates a similar result for ISO 10993-5, stating "ISO 10993-5 / Cytotoxicity study, device extract is cytotoxic", implying that this is an acceptable finding or that a rationale for it exists, but the detail is incomplete in the provided text. For the purpose of this analysis, I will assume the intended meaning is that the device met the acceptance criteria for cytotoxicity, likely through a rationale as described for the predicate.

Study Details

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

   • Watertightness Test (ASTM D5151): The result "0/125/Pass" indicates a sample of 125 gloves was tested.
   • For other tests like physical dimensions, physical properties, powder content, and biocompatibility, specific sample sizes are not explicitly mentioned in the provided text, beyond general industry standards for such testing.
   • Data Provenance: The studies were non-clinical laboratory tests performed by the manufacturer (CHIFENG HUAWEI MEDICAL SCIENCE & TECHNOLOGY CO.,LTD.) in China, as indicated by the submitter's address. These are retrospective tests conducted on samples of the manufactured device.

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

   • This section relates to the evaluation of human interpretation or diagnostic accuracy using expert consensus. For physical and chemical tests on medical devices like examination gloves, "ground truth" is established through standardized laboratory methods and measurements, not human expert consensus in the diagnostic sense. Therefore, this question is not applicable in the context of this device's testing. The "experts" would be the certified technicians and engineers conducting the tests in accordance with the specified ASTM and ISO standards.

3. Adjudication method for the test set:

   • Not applicable as the tests are objective measurements and laboratory analyses against predefined criteria, not subjective human evaluations requiring adjudication.

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 disposable nitrile examination glove, not an AI-powered diagnostic or imaging device. Therefore, MRMC studies and AI-assisted performance improvements are irrelevant to its evaluation.

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

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

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

   • The "ground truth" for the non-clinical tests is established by adhering to widely accepted and validated international standards (ASTM and ISO). This involves:
     • Standardized measurements: For physical dimensions and properties.
     • Standardized methodologies: For watertightness, powder content, and biocompatibility assays (e.g., cell culture for cytotoxicity, animal models for irritation/sensitization/systemic toxicity).
   • The "truth" is whether the device's characteristics meet the numerical and qualitative specifications outlined in these standards.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

   • Not applicable, as there is no training set.

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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 four sizes: small, medium, large, and extra-large. The subject device is non-sterile.

Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves

This document outlines the acceptance criteria and details the studies conducted to demonstrate that the "Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)" meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For Carmustine (BCNU) and ThioTepa, the device performance did not meet the implicitly accepted longer breakthrough times of the predicate device for safe use, and as such, a warning was issued for non-use with these specific drugs. For other drugs, the device demonstrated comparable or superior performance to the predicate.

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for each test. However, for the Watertightness Test (ASTM D5151), the result "0/125/Pass" indicates a sample size of 125 gloves were tested, and none failed.

The data provenance is implied to be prospective bench testing conducted specifically for the submission of this device, presumably within China, given the manufacturer's and correspondent's addresses. There is no information provided regarding country of origin of data beyond the manufacturer's location.

3. Number of Experts and Qualifications for Ground Truth

This section is not applicable as the studies are primarily bench testing of physical and chemical properties of a medical device (gloves). The "ground truth" for these tests is established by published ASTM and ISO standards and their specified methodologies, not by expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable as the studies involve objective physical and chemical testing against established standards, not interpretation of data requiring adjudication.

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

This is not applicable. The device is a medical glove, and the evaluation does not involve diagnostic imaging or human-in-the-loop performance with AI.

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

This is not applicable. The device is a medical glove, not an algorithm, and its performance is assessed directly through physical and chemical testing.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

• Established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards: These standards define the test methodologies, performance criteria (e.g., minimum tensile strength, maximum powder content, minimum breakthrough times for chemotherapy drugs, irritation/sensitization levels), and acceptable limits.
• Objective laboratory measurements: Physical dimensions, tensile strength, elongation, watertightness, powder content, and chemical permeation breakthrough times were measured directly according to the specified standard test methods.

8. Sample Size for the Training Set

This is not applicable. The device is a physical product (medical gloves), not an AI algorithm that requires a training set. The performance is based on direct testing of the product itself.

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

This is not applicable as there is no training set for this type of device. The "ground truth" for the performance evaluation is established by the relevant ASTM and ISO standards as mentioned in point 7.

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

The proposed device is Powder Free Disposable Nitrile Examination gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

The document describes the acceptance criteria and the results of the non-clinical performance testing for the "Disposable Nitrile Examination gloves."

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Skin Sensitization, Skin Irritation, and Cytotoxicity Tests: The number of biological samples (animals or cells) used is not explicitly stated, but the results refer to "All animals" and "L-929 cells." The provenance of this data (e.g., country of origin, retrospective/prospective) is not specified.
• Residual Powder, Freedom from Holes, Dimensions, and Physical Properties Tests: These tests are performed on the device itself, not human or animal subjects in the same way.
  • Freedom from Holes: 125 gloves were tested.
  • For other physical property tests (e.g., dimensions, tensile strength), the exact number of gloves or samples is not explicitly mentioned, but the results represent the performance of the device samples.
  • The provenance of the data (e.g., country of origin of the data, retrospective or prospective) is not specified.

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

This document describes non-clinical performance testing for a medical device (examination gloves). The ground truth for these tests is established by adhering to established international and national standards (ISO 10993-10, ISO 10993-5, ASTM D6124, ASTM D5151, ASTM D6319) and their defined methodologies and acceptance criteria. There is no mention of "experts" in the sense of clinical reviewers for diagnostic accuracy, as this is not a diagnostic device. The "ground truth" is the objective measurement against the specified standard.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study involving human interpretation of data requiring adjudication. The tests involve objective measurements and comparisons against predefined standards.

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

No, an MRMC comparative effectiveness study was not done. This is a non-clinical performance study for examination gloves, not an AI-assisted diagnostic or interpretative system that would involve human readers.

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

No, a standalone performance study in the context of an algorithm or AI system was not done. This device is an examination glove, and the tests performed are physical and biological material property tests.

7. Type of Ground Truth Used:

The ground truth used for these tests is based on established industry standards and specifications (e.g., ISO 10993-10, ISO 10993-5, ASTM D6124, ASTM D5151, ASTM D6319). These standards define the acceptable range or criteria for various physical and biological properties of the device.

8. Sample Size for the Training Set:

Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.

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

Not applicable, as there is no training set for a machine learning/AI model.

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The DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device, DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.

The proposed device is not provided as sterilized The proposed device is made of Nitrile.

This document is a 510(k) Summary for a medical device called "DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue)". It is an FDA submission to demonstrate substantial equivalence to a legally marketed predicate device.

The section providing acceptance criteria and performance data is "Table 5 Performance Test Results Summary" on pages 8-10.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Physical/Performance Tests:
  • Freedom from holes (ASTM D5151): 200 samples (from "No water leakage is inspected form 200 samples").
  • Other physical/performance tests (Tensile Strength, Elongation, Dimensions, Powder Residue): Not explicitly stated, but typically these tests use statistical sampling plans from the respective ASTM standards. For example, ASTM D6319 often references sampling procedures. The reported values are averages, implying multiple samples were tested for each size.
• Sample Size for Biocompatibility Tests (ISO 10993-series): Not explicitly stated, but standard protocols for these tests typically involve a specific number of animals/samples per test.
• Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective nature. However, the sponsor and submission correspondent are based in China, suggesting the testing was likely conducted there or overseen by labs affiliated with the manufacturer. The tests are bench tests ("Summary of Non-Clinical Testing"), so they are experimental in nature, not retrospective or prospective clinical data.

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

This document describes performance testing of a physical medical device (examination gloves) against established ASTM and ISO standards. It does not involve human interpretation of medical images or diagnoses that would require expert "ground truth" establishment in the way AI/ML devices do. Therefore, this section is not applicable for this type of device and testing. The "ground truth" here is the objective measurement against the specified standard criteria.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving subjective human assessment or consensus on, for example, diagnostic findings. The tests involve objective measurements and established physical/chemical testing protocols.

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

No. This is a 510(k) submission for examination gloves, which are Class I devices. It's a non-clinical bench test report to demonstrate substantial equivalence based on physical and safety characteristics. MRMC studies are typically performed for AI/ML-enabled diagnostic devices where human reader performance is a critical factor.

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

Not applicable. This device is a physical product (gloves), not an algorithm or AI/ML software.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by:

• Standard Specifications: Requirements outlined in ASTM D6319-19, ASTM D5151-19, ASTM D6124-17 (for physical performance and holes).
• Biocompatibility Standards: ISO 10993-10:2010 and ISO 10993-11:2017 (for irritation, sensitization, and systemic toxicity).

These are objective, measurable criteria established by recognized national and international standards bodies.

8. The Sample Size for the Training Set

Not applicable. This device is a manufactured product, not a software algorithm that requires a "training set" in the machine learning sense. The manufacturer's production processes are subject to Good Manufacturing Practices (GMP) and Quality System (QS) regulations, which ensure consistent product quality, but this isn't a "training set" like in AI/ML.

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

Not applicable, as there is no "training set" in the context of this device. The manufacturing process is controlled by quality systems rather than data-driven machine learning training.

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

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.

The provided text describes the non-clinical testing performed for a Class I medical device, "Disposable Nitrile Examination Gloves" (K211073). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the efficacy of an AI/ML algorithm. Therefore, many of the requested bullet points, particularly those related to AI algorithm performance, human-in-the-loop studies, and ground truth establishment for training sets, are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and study results for this specific device.

Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves (K211073)

The provided document details non-clinical tests conducted to verify the safety and performance of the "Disposable Nitrile Examination Gloves" (K211073) against established standards and to demonstrate substantial equivalence to a predicate device (K181106).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Cytotoxicity, Skin Sensitization, Skin Irritation, Acute Systemic Toxicity: Sample sizes are not explicitly stated as numerical values for these biological tests but refer to "test article" which implies sufficient samples as per the respective ISO standards. The data provenance is not specified beyond being part of the submission for a Chinese manufacturer; presumably, the tests were conducted under controlled laboratory conditions, not on human patients or retrospectively/prospectively collected clinical data.
• Watertightness Test:
  • Sample Demand: 125 gloves
  • Batch size: 35,000 gloves (for lot-by-lot inspection, implies the sample is drawn from a manufacturing lot)
  • Provenance: Not specified, but generally implies in-house or contracted lab testing for manufacturing batches.
• Physical Dimensions Test:
  • Sample Demand: 13 gloves
  • Batch size: 35,000 gloves
  • Provenance: Not specified.
• Determination of Physical Properties:
  • Sample Demand: 13 gloves
  • Batch size: 35,000 gloves
  • Provenance: Not specified.
• Surface Powder Test:
  • Sample size: 5 sub-samples (N=5) as per Table 1 (page 5), although another section mentions "3 sets of 2 gloves/batch". The results section states "Mean: 0.18mg/glove" for a test on 5pcs sub-samples (N=5).
  • Provenance: Not specified.

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

• Not Applicable. This document describes non-clinical, laboratory-based physical and biological performance tests, not AI algorithm validation requiring expert human ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. This is not a human interpretation study. Acceptance is determined by meeting predefined numerical or qualitative criteria specified in the relevant ASTM/ISO 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 document pertains to the regulatory clearance of a physical medical device (examination gloves), not an AI/ML diagnostic tool. There is no AI component.

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

• Not Applicable. No AI algorithm is involved.

7. The Type of Ground Truth Used

• Objective Measurement and Standard Compliance: The "ground truth" for these tests is based on objective laboratory measurements (e.g., water leakage, dimensions, tensile strength, residual powder) and predefined biological responses in accordance with internationally recognized standards (ASTM, ISO). For biocompatibility, it's about whether the material elicits a specific biological reaction (e.g., cytotoxicity, irritation, sensitization).

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" and therefore no ground truth establishment for it in this context.

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The Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device, Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Purple-Blue. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for Disposable Nitrile Examination Gloves.

Important Note: This document pertains to the clearance of a medical device – specifically disposable nitrile examination gloves. The concepts of "AI models," "human readers," "effect size," "multi-reader multi-case (MRMC) comparative effectiveness studies," "standalone algorithms," and "ground truth establishment for training sets" as typically applied to AI/ML medical devices do not apply to this product. This submission focuses on the physical and performance characteristics of the gloves themselves compared to a predicate device.

Therefore, the answers to several of your requested points will be "Not Applicable" or refer to standard laboratory testing rather than AI/ML model validation.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue)

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

• Sample Size for Physical/Performance Tests:
  • Freedom from Holes (ASTM D5151): 200 samples were inspected for each color (Blue and Purple-Blue). This is per the standard's sampling requirements for AQL testing.
  • Residual Powder (ASTM D6124): Quantities of powder were measured across various sizes (XS, S, M, L, XL) for both colors. The exact number of gloves per size/color tested isn't explicitly stated but would be based on the ASTM D6124 standard.
  • Physical Property Characteristics (Tensile Strength, Elongation): Not explicitly stated, but standard test methods (ASTM D412, D573) specify the number of specimens to be tested per batch.
  • Physical Dimensions: Not explicitly stated, but standard test methods (ASTM D412, D3767) specify the number of specimens to be measured.
  • Biocompatibility Tests (ISO 10993-10, -11): These tests involve a specific number of animal subjects (e.g., guinea pigs for sensitization, mice for systemic toxicity, rabbits for irritation). The exact number isn't in the summary but is defined by the ISO standards.
• Data Provenance: The tests appear to be internal bench tests conducted by or for the manufacturer. No specific country of origin for the test data is given beyond the company's location (China). These are prospective tests performed specifically for this 510(k) submission, not retrospective data.

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

Not Applicable. This is not an AI/ML device where "ground truth" is established by human experts reviewing medical images. The "ground truth" here is the objective measurement against established ASTM and ISO standards for physical properties, chemical residue, and biological safety of gloves. These measurements are performed by trained technicians in a laboratory setting, not by medical experts interpreting data like radiologists.

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/ML device; there is no human interpretation or adjudication involved in the test results. The tests are objective measurements against pre-defined quantitative criteria.

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

Not Applicable. MRMC studies are used to assess the impact of AI on human reader performance, typically in imaging diagnostics. This device is a physical product (gloves) and does not involve human readers interpreting AI output.

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 model. Its performance is measured directly through physical, chemical, and biological testing.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Reference Standards: Adherence to established and internationally recognized industry standards (ASTM D6319, D5151, D6124, ISO 10993-10, ISO 10993-11).
• Laboratory Measurements: Objective measurements of physical properties (e.g., length, width, thickness, tensile strength, elongation), chemical properties (residual powder), and biological responses (irritation, sensitization, systemic toxicity) using calibrated equipment and validated protocols.

8. The Sample Size for the Training Set

Not Applicable. This product is not an AI/ML model, and therefore, there is no "training set." The product's characteristics are inherent to its manufacturing process and materials, and its performance is validated through defined testing, not a learned model.

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

Not Applicable. As there is no training set for this type of device, this question is irrelevant.

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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 or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.

The proposed Disposable Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, and is made of nitrile (Acrylonitrile-butadiene copolymer) and chemical additives. It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile.

The provided text describes the acceptance criteria and performance of "Disposable Nitrile Examination Gloves" (K210897) in comparison to a predicate device (K192333), as part of an FDA 510(k) summary.

Here's a breakdown of the requested information:

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

| Characteristics | Acceptance Criteria | Proposed Device Performance (Disposable Nitrile Examination Gloves - K210897) | Predicate Device Performance (Blue Nitrile Examination Gloves Powder Free - K192333) |
|---------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| Comparison |
| General Comparison | | | | |
| 510K Number | / | K210897 | K192333 | - |
| Product Code | LZA | LZA | LZA | Same |
| Classification | Class I (21 CFR 880.6250) | Class I (21 CFR 880.6250) | Class I (21 CFR 880.6250) | Same |
| Intended Use | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The device is for over-the-counter use. | A powder free 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. The device is for over-the-counter use. | A powder free patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Same |
| Material Use | Nitrile | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Blue | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Performance Testing | | | | |
| Dimensions (ASTM D6319-19) | Overall Length (mm): 220 mm = (sizes XS-S), 230 mm = (sizes M-XL); Width (± 10 mm): Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm; Thickness at Finger (mm): All Sizes = 0.05mm; Thickness at Palm (mm): All Sizes = 0.05mm | Length (mm): 220 mm = (sizes XS-S), 230 mm = (sizes M-XL); Width (± 10 mm): Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm; Thickness-Finger (mm): All Sizes ≥ 0.05mm; Thickness-Palm (mm): All Sizes ≥ 0.05mm | Size: M, Length Min: 230mm, Palm Width Min: 95+/-10mm, Finger Thickness min: 0.05 mm, Palm Thickness min: 0.05 mm | Same |
| Tensile Strength (Before Aging ASTM D6319-19) | $\ge$ 14 MPa | > 14 min MPa | > 14 min MPa | Same |
| Ultimate Elongation (Before Aging) | $\ge$ 500% | 500 min % | 500 min % | Same |
| Tensile Strength (After Aging ASTM D6319-19) | $\ge$ 14 MPa | $\ge$ 14 min MPa | $\ge$ 14 min MPa | Same |
| Ultimate Elongation (After Aging) | $\ge$ 400% | 400 min % | 400 min % | Same |
| Freedom from Holes (ASTM D5151) | AQL 2.5 Inspection Level G-1 | Passes AQL-2.5 | Passes AQL-2.5 | Same |
| Residual Powder (ASTM D6124) | $\le$ 2.0 mg/pc | $\le$ 2.0 mg/pc | $\le$ 2.0 mg/pc | Same |
| Biocompatibility Testing | | | | |
| Primary Skin Irritation Test (ISO 10993-10) | Not an irritant | Under the conditions of the test, the test article would be considered a non-irritant. | Under the condition of study not an irritant. | Same |
| Dermal Sensitization Assay (ISO 10993-10) | Not a sensitizer | Under the conditions of this study, there is no evidence of skin sensitization in guinea pigs was found. | Under the conditions of the study not a sensitizer. | Same |
| Acute Systemic Test (ISO 10993-11) | No mortality or evidence of systemic toxicity | Under the conditions of this study, there is no mortality or evidence of systemic toxicity from the extracts. The test met the test requirements. | Under the condition of study the device extracts do not pose a systemic toxicity concern. | Same |
| Material Mediated Pyrogenicity (ISO 10993-11/USP 41<151>) | No febrile reaction; meets requirements | Under the conditions of this study, the test article would be considered no febrile reaction. The test article meets the test requirements. | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. | Same |
| In Vitro Cytotoxicity (ISO 10993-5) | Not cytotoxic (or acceptable cytotoxicity with further testing/justification) | Under the conditions of this study, the MEM test extracts would be considered cytotoxic potential. | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. | Same |
| Intracutaneous Reactivity Test (ISO 10993-10) | Polar and non-polar extract score less 1.0; requirements met | The test result showed that the polar and non-polar extract of the final test sample score is less 1.0, the requirements of the test are met. | Not available. | N/A |

A key point is that for all tested Biocompatibility characteristics, the proposed device's performance aligns with the predicate device, with one notable difference for "In Vitro Cytotoxicity" where both devices were found to be cytotoxic, but the predicate device had "Additional testing was performed to determine if this was a systemic toxicity concern," implying the cytotoxicity might have been addressed or deemed acceptable in the predicate's clearance. The proposed device's statement "would be considered cytotoxic potential" suggests a similar outcome, and the "Same" comparison indicates this was consistent with the predicate.

The study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is a non-clinical test program that evaluates the "Disposable Nitrile Examination Gloves" against recognized industry standards and FDA guidance. This is explicitly stated in section 8: "The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical Glove Guidance Manual Document, issued on January 22, 2008."

The comparison tables (Table II - Performance Testing Comparison Table and Table III - Biocompatibility Testing Comparison Table) demonstrate that the proposed device's performance meets or exceeds the specified acceptance criteria and is substantially equivalent to the predicate device.

Absence of information for AI-specific questions:

The provided document is an FDA 510(k) summary for a medical device (disposable nitrile examination gloves). It does not pertain to an AI/ML-enabled medical device. Therefore, the following information is not applicable and not present in the document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

The testing performed for this device relates to physical properties (dimensions, tensile strength, elongation, freedom from holes, residual powder) and biocompatibility (skin irritation, sensitization, systemic toxicity, pyrogenicity, cytotoxicity, intracutaneous reactivity), which are standard evaluations for such a product.

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

The proposed device is Powder Free Disposable Nitrile Examination gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

The provided document describes the acceptance criteria and performance data for Disposable Nitrile Examination Gloves. The study primarily focuses on non-clinical tests to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Watertight (ASTM D5151): Sample size = 125 pcs (from a batch size of 35000)
• Physical Properties (ASTM D412): Sample size = 8 pcs (from a batch size of 35000)
• Residual Powder (ASTM D6124): Sample size = 5 pcs
• Biocompatibility: Specific sample sizes are not explicitly stated for individual tests but imply testing performed on the device material.
• Data Provenance: The document (K211264) is a 510(k) submission from Shenzhen Shiqiao Science and Technology Co. LTD, China. The testing was conducted as part of this premarket notification. The data is prospective for this submission, meaning it was gathered specifically to support this application.

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 performed are objective, laboratory-based physical and chemical tests (e.g., measuring dimensions, tensile strength, presence of holes, powder content, biological reactions). They do not involve human interpretation of complex data like medical images or clinical outcomes that would require expert consensus for ground truth.

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

This information is not applicable for the type of objective tests performed on the gloves. Adjudication methods are typically used in studies involving subjective assessments or disagreements among multiple human readers.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or CAD (Computer-Aided Detection) devices, which involve human interaction and diagnostic tasks. The device in question is a disposable medical glove, and its performance is evaluated through physical and chemical properties.

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

This information is not applicable. The device is a physical product (nitrile examination gloves), not an algorithm or AI system.

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

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

• Objective measurements and standardized test procedures: For physical properties (tensile strength, elongation, dimensions), watertight integrity, and residual powder content, the ground truth is the direct measurement against the specified acceptance criteria of the ASTM standards.
• Biological assay results: For biocompatibility (irritation, sensitization, cytotoxicity), the ground truth is derived from the results of standardized biological assays (ISO 10993 series) interpreted against established biological safety criteria.

8. The sample size for the training set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The gloves are manufactured and tested against predefined specifications.

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

This information is not applicable as there is no training set for this device.

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