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

The subject device is powder free nitrile examination gloves. The subject device is available in color blue and white, and it provides five specifications: XS,S, M, L, and XL. The subject device is non-sterile.

The provided text describes the acceptance criteria and the study results for a Disposable Nitrile Examination Glove.

Here's the information extracted and formatted as requested:

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 beyond the implication that sufficient samples were tested to meet the requirements of the listed ASTM and ISO standards. These standards typically define appropriate sampling plans.
• Data Provenance: The text does not specify the country of origin for the data (e.g., where the tests were conducted or the materials sourced from). The study is non-clinical performance testing.

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 described tests are laboratory-based physical and biocompatibility evaluations, not assessments requiring expert interpretation of diagnostic images or clinical scenarios.

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

• This information is not applicable as the described tests are laboratory-based physical and biocompatibility evaluations.

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. This submission is for a disposable nitrile examination glove, not an AI-powered diagnostic device.

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

• This information is not applicable. This submission is for a disposable nitrile examination glove.

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

• The "ground truth" for the performance tests relies on established scientific and engineering standards and methodologies defined by organizations such as ISO and ASTM. For example, for tensile strength, the ground truth is the specified MPa value; for freedom from holes, it's the AQL (Acceptable Quality Limit). For biocompatibility, it's the biological response observed according to the specific ISO test protocols.

8. The sample size for the training set:

• This information is not applicable. This submission is for a physical medical device (glove), not a machine learning or AI algorithm that requires a training set.

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

• This information is not applicable. No training set was used.

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

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

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.7 Minutes Thio-Tepa 10.0 mg/ml 45.7 Minutes

Caution: Testing showed an average breakthrough time of 45.7 minutes with Thio-Tepa

WARNING: Do not use with Carmustine

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 non-sterile and in five sizes: extra-small, small, medium, large, and extra-large.

Below is a summary of the acceptance criteria and the study conducted for the Disposable Nitrile Examination Glove, as detailed in the provided FDA 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document provides sample sizes for specific tests:

• ASTM D5151 (Watertightness): 125 gloves per size (XS, S, M, L, XL) were tested.
• The specific sample sizes for other tests like physical dimensions (ASTM D6319, ASTM D412), powder content (ASTM D6124), chemotherapy drug permeation (ASTM D6978), and biocompatibility (ISO 10993-5, ISO 10993-10) are not explicitly stated in numerical terms (e.g., "n=X"), but are implied to be sufficient to meet the requirements of the respective ASTM and ISO standards.
• Data Provenance: The studies were conducted by the device manufacturer, Inner Mongolia Boming Medical Supplies Co., Ltd., which is located in China. The data would be considered prospective as it involves new testing on the subject device to demonstrate its performance against established standards.

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

This information is not applicable to this device. The "ground truth" for the performance of examination gloves is established by objective, standardized laboratory tests (e.g., ASTM and ISO methods) rather than expert clinical judgment or consensus. These are physical and chemical properties measured according to specific protocols.

4. Adjudication Method for the Test Set:

This is not applicable to this device. As mentioned above, the evaluation relies on objective measurements from standardized test methods, not subjective assessments requiring adjudication by multiple experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or other complex data, and their performance is compared with and without AI assistance. Examination gloves are a Class I device with performance assessed via bench testing, not human interpretation.

6. Standalone (Algorithm Only) Performance:

No, a standalone (algorithm only) performance study was not done. This device is a physical product (examination glove), not an AI algorithm or software. Its performance is evaluated through material and physical property testing, not algorithmic output.

7. Type of Ground Truth Used:

The ground truth used in these studies is based on objective, quantitative measurements obtained through validated and standardized laboratory test methods as defined by:

• ASTM International (formerly American Society for Testing and Materials) standards: ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, and ASTM D6978.
• ISO (International Organization for Standardization) standards: ISO 10993-5 and ISO 10993-10.
  These standards define the methods for measuring physical properties, chemical resistance, and biocompatibility, and the "ground truth" is the result of these measurements compared against the specified acceptance criteria within the standard.

8. Sample Size for the Training Set:

This information is not applicable. The device is not an AI/ML algorithm that requires a "training set" of data. The manufacturing process of examination gloves is based on established engineering principles and quality control, rather than machine learning models.

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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The Disposable Nitrile Examination Glove is a disposable device intended for medical purposes that is 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 blue. It can be available in five specifications: XS, S, M, L and XL. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for a Disposable Nitrile Examination Glove, not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria and study designs that are specific to AI/ML device performance (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable.

The document focuses on demonstrating substantial equivalence of the new glove to a legally marketed predicate device based on material, performance, and biocompatibility standards.

Here's a breakdown of the relevant information from the document related to performance and acceptance criteria for this non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for each specific test, other than for the Watertightness Test (125 samples). The tests are non-clinical (laboratory-based) and conducted to verify compliance with specified ASTM and ISO standards. The data provenance is implied to be from the manufacturer (Anhui Kindguard Medical Supplies Technology Co., Ltd) in China, as it's part of their 510(k) submission. These are experimental results from a lab, not patient data, so "retrospective or prospective" is not applicable in the typical AI/ML sense.

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

This information is not applicable. The device is a medical glove, and its performance is assessed against technical specifications and standardized laboratory tests (e.g., dimensions, tensile strength, hole detection, biocompatibility assays), not through expert interpretation of clinical data like medical images.

4. Adjudication Method for the Test Set

Not applicable. Performance is determined by objective measurements and standardized test procedures, not human 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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is defined by the acceptance criteria specified in internationally recognized standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993 series). These standards provide objective measurement methodologies and thresholds for physical properties and biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device subject to training data.

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

Not applicable. This is not an AI/ML device subject to training data.

In summary, the provided document is for a conventional Class I medical device (disposable examination gloves) and illustrates the data and tests required for a 510(k) clearance based on substantial equivalence. The questions posed are highly specific to AI/ML medical devices, which are not relevant to this submission.

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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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The Disposable Nitrile Examination Glove is a disposable device intended for medical purposes that is 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 Pink/Cool Gary/Green/Rose Gold. 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 a Disposable Nitrile Examination Glove. It details the device, its intended use, and non-clinical testing performed to establish substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • For Watertightness (holes), the result "0/125/Pass" indicates a sample size of 125 gloves were tested.
  • For other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility), specific sample sizes are not explicitly stated in the provided text.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that Jiangsu Cureguard Glove Co., Ltd. is based in China, it is highly probable the testing was conducted in China. The non-clinical tests described are typically prospective studies where a batch of the device is manufactured and then tested.

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

This information is not applicable (N/A) as the device is a physical product (nitrile gloves) and the testing performed consists of objective, quantifiable physical and chemical tests against established standards. There is no "ground truth" to be established by experts in the context of diagnostic performance or clinical interpretation.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reason as point 3. The tests are objective and based on direct measurement or observation against defined criteria, not subjective interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and AI assistance is being evaluated for its impact on their performance. The disposable nitrile examination glove is a Class I medical device and does not involve such diagnostic interpretation.

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

No, a standalone "algorithm only" performance study was not done. This concept applies to AI/ML software as a medical device (SaMD). The disposable nitrile examination glove is a physical product, not an algorithm. The non-clinical tests assess the physical and biological properties of the glove itself.

7. The Type of Ground Truth Used

The "ground truth" used in these non-clinical tests is based on established standard specifications (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993 series). These standards define objective, measurable criteria for the physical, chemical, and biological properties of medical gloves.

8. The Sample Size for the Training Set

This information is not applicable (N/A). There is no "training set" as this device does not involve machine learning or AI algorithms that require training data.

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

This information is not applicable (N/A) for the same reason as point 8.

Ask a specific question about this device

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

These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) 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 five sizes: extra-small, small, medium, large, and extra-large.

The provided text describes the regulatory filing (510(k) Premarket Notification) for a "Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)". This document is for a medical device (a glove), not an AI/Software as a Medical Device (SaMD) or an algorithm. Therefore, the questions related to AI/algorithm performance metrics (such as MRMC studies, standalone algorithm performance, AI assistance effect size, training set sample size, expert ground truth establishment for AI data) are not applicable to this submission.

The acceptance criteria and device performance for this physical medical device are related to its material properties, physical dimensions, and resistance to chemotherapy drugs, as outlined by various ASTM and ISO standards.

Here's the information extracted and formatted according to the request, with clarification where the questions are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The reported results for physical and chemical resistance tests seem to be based on representative samples from production, as per the respective ASTM and ISO standards. The specific sample sizes for each test are implicitly defined by these standard test methods (e.g., ASTM D5151 for watertightness mentions testing 125 gloves per batch/size for AQL).
• Data provenance: Not explicitly stated, however, the manufacturer is Inner Mongolia Cureguard Medical Technology Co.,Ltd. (China), suggesting the testing was likely conducted in China or by labs compliant with international standards, possibly in China or elsewhere. The tests are "non-clinical" bench tests, not involving human data or patient populations. The data is retrospective in the sense that it's generated from manufactured product batches for regulatory submission.

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

This question is not applicable as the device is a physical medical glove, and its performance and safety are assessed through objective laboratory tests governed by international standards (ASTM, ISO), not through expert interpretation of medical images or other data that would require a "ground truth" established by experts in a clinical context. The "ground truth" here is the result of standardized material science and chemical permeation testing.

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

Not applicable. This is not a study requiring human adjudication for data interpretation.

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 medical device, not an AI/SaMD.

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 AI/SaMD.

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

The ground truth for the device's performance is established by the specified international standard test methods (ASTM and ISO standards) for physical properties, chemical resistance, and biocompatibility. For example, for watertightness, the ground truth is the absence of leaks when tested according to ASTM D5151. For chemotherapy drug permeation, the ground truth is the measured breakthrough time and the specific drug concentration in the testing apparatus according to ASTM D6978. For biocompatibility, it's the observed biological response to testing protocols defined in ISO 10993-5 and ISO 10993-10.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/SaMD. There is no "training set" in the context of an algorithm.

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

Not applicable. See point 8.

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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 Glove is a disposable device intended for medical purposes that is 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 Black/Lavender/Navy Blue/Burgundy. It can be available in five specifications: XS,S,M,L and XL.

The subject device is non-sterile.

This document is a 510(k) Premarket Notification for a Disposable Nitrile Examination Glove. It details the device's characteristics and compares it to a predicate device (K171422) to establish substantial equivalence.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

• Watertightness Test (ASTM D5151): The reported performance "0/125/Pass" indicates a sample size of 125 units were tested.
• Other tests: The sample sizes for the remaining tests (Physical Dimensions, Thickness, Physical Properties, Powder Content, Biocompatibility) are not explicitly stated in the provided document.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer is Jiangsu Cureguard Glove Co., Ltd. in China, so it's reasonable to infer the testing was conducted in China, but this is not explicitly confirmed.

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

• This device (Disposable Nitrile Examination Glove) is a Class I medical device, which typically relies on established engineering and materials standards (e.g., ASTM, ISO) rather than expert human interpretation of complex medical images or outcomes.
• Therefore, the concept of "experts" establishing a "ground truth" as it would apply to AI/imaging diagnostics does not apply to the performance testing described for this device. The ground truth is defined by the objective measurement specifications in the referenced standards.

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

• Again, due to the nature of the device and testing (physical and chemical properties measured against objective standards), no adjudication method of expert opinions was used or necessary. The results are based on objective measurements.

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

• An MRMC study is not applicable to this type of device. This device is a disposable examination glove, not an AI-assisted diagnostic tool.

6. 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 or software. The "standalone" performance is simply the device's ability to meet the specified physical, chemical, and biological criteria.

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

• The ground truth for this device's performance testing is defined by objective engineering and material standards (e.g., ASTM D6319 for dimensions, ASTM D412 for physical properties, ASTM D5151 for watertightness, ASTM D6124 for powder content, and ISO 10993 series for biocompatibility). These standards provide the measurable criteria that the device must meet.

8. The sample size for the training set

• This is not applicable as the device is a physical product, not an AI model requiring a training set.

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

• This is not applicable as the device is a physical product, not an AI model.

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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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