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510(k) Data Aggregation
(86 days)
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color, powder free and non sterile. The device is available in Extra Small, Small, Medium, Large and Extra Large sizes.
The provided document details the acceptance criteria for "Blue Nitrile Examination Gloves Powder Free" and presents the results of non-clinical testing to demonstrate the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria (Predicate / Subject Device) | Reported Device Performance (Subject Device) |
|---|---|---|---|
| Dimensions | |||
| Length | ASTM D6319-2019 | Min 230 mm for all sizes | X-Small: 245 mm, Small: 245 mm, Medium: 246 mm, Large: 248 mm, X-Large: 248 mm |
| Width | ASTM D6319-2019 | X-small: 70+/-10 mm, Small: 80+/-10 mm, Medium: 95+/-10 mm, Large: 110+/-10 mm, X-Large: 120+/-10 mm | X-small: 76 mm, Small: 84 mm, Medium: 94 mm, Large: 105 mm, X-Large: 115 mm |
| Physical Properties | |||
| Thickness | ASTM D6319-2019 | Palm min 0.05 mm, Finger min 0.05 mm for all sizes | Palm: 0.09 mm (all sizes), Finger: 0.15 mm (all sizes) |
| Tensile Strength (Before Aging) | ASTM D6319-2019 | Min 14 Mpa for all sizes | X-Small: 22.76 Mpa, Small: 22.77 Mpa, Medium: 24.46 Mpa, Large: 24.51 Mpa, X-Large: 24.59 Mpa |
| Tensile Strength (After Aging) | ASTM D6319-2019 | Min 14 Mpa for all sizes | X-Small: 20.50 Mpa, Small: 20.50 Mpa, Medium: 21.81 Mpa, Large: 21.95 Mpa, X-Large: 22.05 Mpa |
| Ultimate Elongation (Before Aging) | ASTM D6319-2019 | Min 500% for all sizes | X-Small: 884%, Small: 885%, Medium: 888%, Large: 891%, X-Large: 892% |
| Ultimate Elongation (After Aging) | ASTM D6319-2019 | Min 400% for all sizes | X-Small: 867%, Small: 868%, Medium: 870%, Large: 872%, X-Large: 875% |
| Water Tight (Detection of Holes) | ASTM D5151-2019 | Passes AQL-1.5 | Gloves Passes AQL 1.5 |
| Powder Residue | ASTM D6124-06 (Reapproved 2017) | ≤2 mg/glove | X-small: 0.16 mg/glove, Small: 0.16 mg/glove, Medium: 0.16 mg/glove, Large: 0.16 mg/glove, X-Large: 0.16 mg/glove |
| Biocompatibility | |||
| Primary Skin Irritation | ISO 10993-10 | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Dermal Sensitization | ISO 10993-10 | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| In vitro Cytotoxicity | ISO 10993-5:2009 | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic (Note: This result is listed as "cytotoxic" while the acceptance criteria is "non cytotoxic", which could be a typo or indicates further consideration is needed). |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern |
| Material Mediated Pyrogenicity | ISO 10993-11:2017/USP 41<151> | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response |
From the table, the device performance meets or exceeds the acceptance criteria for all tested characteristics, with the exception of the "In vitro Cytotoxicity" test where the reported result is "cytotoxic" while the acceptance criteria is "non cytotoxic". This discrepancy needs clarification. However, in the "SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS", the predicate also states "cytotoxic" for in vitro cytotoxicity, implying it might be an acceptable characteristic for this type of device or a different interpretation of cytotoxicity specific to gloves.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each test. For example, for "Water Tight (1000 ml)" test, it mentions "Passes AQL-1.5", which implies a sampling plan was used according to the ASTM standard, but the specific number of gloves tested is not provided. The data provenance (country of origin, retrospective/prospective) is also not specified, beyond the fact that the tests were conducted according to international standards (ASTM, ISO).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device under review is a medical glove, and the evaluation relies on adherence to established physical, chemical, and biological performance standards, not expert interpretation of medical images or cases. Ground truth for these tests is based on objective measurements and established test methodologies defined in the ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., medical images) where expert consensus is required. The testing for this device involves objective, quantitative measurements against predefined 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
This information is not applicable. The device is a medical glove. MRMC studies are relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret images with or without AI assistance.
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 medical glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is based on the objective measurements and predefined thresholds within recognized international standards (ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06, ISO 10993-10, ISO 10993-5:2009, ISO 10993-11:2017, USP 41<151>). For example:
- Dimensions: Measured length and width against minimum/range requirements.
- Physical Properties: Measured tensile strength and elongation against minimum percentage requirements.
- Water Tightness: Statistical sampling and inspection against an Acceptable Quality Level (AQL).
- Biocompatibility: Observation of biological responses (e.g., irritation, sensitization) following standardized protocols, compared against criteria for "not an irritant" or "not a sensitizer".
8. The sample size for the training set
This information is not applicable. The device is a medical glove, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of medical device.
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(285 days)
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free.
The provided text is a 510(k) summary for "Blue Nitrile Examination Gloves Powder Free". It details the device's characteristics, intended use, and a comparison to a predicate device. The document explicitly states that clinical testing is not applicable and that clinical data is not needed for gloves or for most devices cleared by the 510(K) process.
Therefore, there is no information in the provided text regarding a study that proves the device meets acceptance criteria related to AI or human-in-the-loop performance, as this is a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool.
However, I can extract the acceptance criteria and reported performance for the non-clinical tests conducted on the device, which are relevant for demonstrating its substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D6319-2019 | ||
| Length | Min 230 mm for all sizes | X-Small: 303 mmSmall: 304 mmMedium: 305mmLarge: 306mmX-Large: 307mm | |
| Width (for specific sizes) | X-small: 70+/-10 mmSmall: 80+/-10 mmMedium: 95+/-10mmLarge: 110+/-10 mmX-Large: 120+/-10 mm | X-small: 74 mmSmall: 84 mmMedium: 94 mmLarge: 104 mmX-Large: 115 mm | |
| Physical Properties | ASTM D6319-2019 | ||
| Before Aging: | |||
| Tensile Strength | 14 Mpa Min for all sizes | X-Small: 18.44 MpaSmall: 18.49 MpaMedium: 18.56 MpaLarge: 18.62 MpaX-Large: 18.64 Mpa | |
| Ultimate Elongation | 500% Min for all sizes | X-Small: 683%Small: 687%Medium: 692%Large: 695%X-Large: 698% | |
| After Aging: | |||
| Tensile Strength | 14 Mpa Min for all sizes | X-Small: 17.49 MpaSmall: 17.53 MpaMedium: 17.65 MpaLarge: 17.71 MpaX-Large: 17.76 Mpa | |
| Ultimate Elongation | 400% Min for all sizes | X-Small: 656%Small: 660%Medium: 663%Large: 666%X-Large: 669% | |
| Thickness | ASTM D6319-2019 | Palm 0.05 mm minFinger 0.05 mm min | Palm: 0.10 mm for all sizesFinger: 0.12 mm for all sizes |
| Water Tightness | ASTM D5151-2019 | AQL-1.5 | Passes AQL 1.5 |
| Powder Residue | ASTM D6124-06 (Reapproved 2017) | 2 mg/glove Max | X-Small: 0.21 mg/gloveSmall: 0.21 mg/gloveMedium: 0.22 mg/gloveLarge: 0.22 mg/gloveX-Large: 0.22 mg/glove |
| Biocompatibility | |||
| Primary Skin Irritation | ISO 10993-10 | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Dermal Sensitization | ISO 10993-10 | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| In vitro Cytotoxicity | ISO 10993-5:2009 | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern |
| Material Mediated Pyrogenicity | ISO 10993-11:2017 / USP 41 <151> | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. |
Regarding the other requested information (2-9), as a physical medical device (gloves) and not an AI/software device, these questions are not applicable to the context of the provided document.
- 2. Sample size used for the test set and the data provenance: Not applicable. (These are physical tests on glove samples, not a test set for AI performance).
- 3. Number of experts and qualifications: Not applicable. (These are standardized physical and biological tests).
- 4. Adjudication method: Not applicable. (These are standardized physical and biological tests).
- 5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted image interpretation or similar.
- 6. Standalone (algorithm only without human-in-the-loop performance): Not applicable. This is for AI algorithms.
- 7. Type of ground truth used: Not applicable in the AI sense. The "ground truth" for these tests comes from established industry standards (ASTM, ISO, USP) for physical and chemical properties and biological responses.
- 8. Sample size for the training set: Not applicable. Applies to AI/machine learning.
- 9. How the ground truth for the training set was established: Not applicable. Applies to AI/machine learning.
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(150 days)
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
JR MEDIC Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
The provided text is a 510(k) Premarket Notification for "Blue Nitrile Examination Gloves Powder Free." It details the device's technical characteristics, non-clinical performance, and comparison to a predicate device to demonstrate substantial equivalence.
This document describes the testing of a medical device (examination gloves), which
Does not involve AI, machine learning, or complex algorithmic performance in its functionality or assessment. The tests performed are
physical, chemical, and biological compatibility tests of the material itself.
Therefore, the requested information regarding acceptance criteria and study proving AI/ML device performance (such as sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this document. The document describes the data and testing for a Class I medical device (gloves) and demonstrates its "substantial equivalence" to an existing predicate device, primarily through non-clinical bench testing and biocompatibility studies.
However, I can extract the acceptance criteria and reported performance for the physical and biological properties of the gloves, as provided in the document.
Acceptance Criteria and Reported Device Performance for Blue Nitrile Examination Gloves Powder Free
Since this is a physical medical device (gloves) and not an AI/ML-driven device, the criteria typically associated with AI/ML performance (e.g., AUC, sensitivity, specificity for a diagnostic algorithm) are not relevant here. Instead, the acceptance criteria relate to the physical properties, chemical composition, and biocompatibility of the gloves, demonstrating they meet established standards for medical examination gloves.
Here's the table of acceptance criteria and reported device performance based on the non-clinical testing summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Physical Properties | ||||
| Length | ASTM D6319-10 (Reapproved 2015) | To determine the length of the gloves | Min 230 mm for all sizes | X-Small: 404 mmSmall: 404 mmMedium: 405 mmLarge: 404 mmX-Large: 404 mm |
| Width | ASTM D6319-10 (Reapproved 2015) | To determine the width of the gloves | X-small: 70+/-10 mmSmall: 80+/-10 mmMedium: 95+/-10 mmLarge: 110+/-10 mmX-Large: 120+/-10 mm | X-small: 74 mmSmall: 84 mmMedium: 94 mmLarge: 105 mmX-Large: 115 mm |
| Thickness | ASTM D6319-10 (Reapproved 2015) | To determine the thickness of the gloves | Palm 0.05 mm minFinger 0.05 mm min for all sizes | Palm:X-Small: 0.20mmSmall: 0.19mmMedium: 0.20mmLarge: 0.20mmX-Large: 0.20mmFinger:X-Small: 0.22mmSmall: 0.21mmMedium: 0.22mmLarge: 0.21mmX-Large: 0.22mm |
| Tensile Strength | ASTM D6319-10 (Reapproved 2015) | To determine the physical properties | Before Ageing: 14Mpa Min for all sizesAfter Ageing: 14Mpa Min for all sizes | Before Ageing:X-Small: 22.0MpaSmall: 23.0MpaMedium: 25.6MpaLarge: 24.0MpaX-Large: 24.5MpaAfter Ageing:X-Small: 18.5MpaSmall: 20.5MpaMedium: 22.0MpaLarge: 21.0MpaX-Large: 21.7Mpa |
| Ultimate Elongation | ASTM D6319-10 (Reapproved 2015) | To determine the physical properties | Before Ageing: 500% Min for all sizesAfter Ageing: 400% Min for all sizes | Before Ageing:X-Small: 898%Small: 896%Medium: 868%Large: 899%X-Large: 874%After Ageing:X-Small: 872%Small: 861%Medium: 828%Large: 869%X-Large: 853% |
| Water Tightness (Holes) | ASTM D5151-06 (Reapproved 2015) | To determine the holes in the gloves | AQL 2.5 | Gloves pass AQL 1.5 (This meets or exceeds the AQL 2.5 criteria, as a lower AQL indicates fewer allowable defects). |
| Residual Powder | ASTM D6124-06 (Reapproved 2017) | To determine the residual powder in the gloves | 2 mg/glove Max | X-small: 0.16 mg/gloveSmall: 0.20 mg/gloveMedium: 0.21 mg/gloveLarge: 0.20 mg/gloveX-Large: 0.21 mg/glove |
| Biocompatibility | - | |||
| Primary Skin Irritation | ISO 10993-10:2010(E) | To determine the potential to produce dermal irritation in Rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Dermal Sensitization | ISO 10993-10:2010(E) | To determine skin sensitization potential in Guinea Pig | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| In vitro Cytotoxicity | ISO 10993-5:2009(E) | To evaluate in vitro cytotoxic potential in L-929 mouse fibroblasts cells | Under the conditions of study non cytotoxic | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. (This indicates an initial result that was followed up to ensure safety). |
| Acute Systemic Toxicity | ISO 10993-11:2017(E) | To determine acute systemic toxicity potential in swiss Albino mice | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern. (This addresses the concern from the cytotoxicity test). |
| Material Mediated Pyrogenicity | ISO 10993-11:2017(E) / USP 41 <151> | To determine pyrogenic potential in New Zealand white Rabbits | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. |
Since the device is a simple medical examination glove and not an AI/ML system, the following points regarding AI/ML study design are explicitly not applicable to the data provided in this document:
- Sample sizes used for the test set and the data provenance: Not applicable. Performance is based on physical and chemical tests on manufactured gloves, not a "test set" of patient data for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves is defined by adherence to physical standards (ASTM) and biological safety (ISO, USP), not expert annotation of medical images/data.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for performance assessment of diagnostic/AI tools with human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. The "ground truth" here is compliance with established international standards for physical properties and biocompatibility of medical gloves.
- The sample size for the training set: Not applicable. There is no training set as there is no AI/ML model.
- How the ground truth for the training set was established: Not applicable.
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