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510(k) Data Aggregation
(93 days)
Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile). The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I) for single use only. The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document is a 510(k) Premarket Notification for Disposable Medical Nitrile Examination Gloves (Non-Sterile). This type of document is for a medical device that does not use AI/ML, and therefore, the requested information regarding AI/ML device performance and related study details is not applicable.
However, I can extract the acceptance criteria and performance data for this device based on the non-clinical testing summary provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance/Result |
|---|---|---|---|
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test | To determine the width, length, and thickness of the gloves | Width:80mm ±10mm (for small size)95mm ±10mm (for medium size)110 mm ±10mm (for large size)Length:220 mm (Minimum) (for small size)230 mm (Minimum)(for medium, large size)Thickness:Finger -0.05 mm (Minimum) (for small, medium, large size)Palm -0.05 mm (Minimum)(for small, medium, large size) | Width:small size: 82 to 89mmmedium size: 91 to 96mmlarge size: 115 to 116mmLength:small size: 230mm (minimum)medium size: 240mm (minimum)large size: 238mm (minimum)Thickness:Finger:small size: 0.12mm (minimum)medium size: 0.13mm (minimum)large size: 0.12mm (minimum)Palm:small size: 0.08 mm (minimum)medium size: 0.08mm (minimum)large size: 0.09 mm (minimum)Passed |
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test | To determine the tensile strength and ultimate elongation before and after acceleration aging | Before Acceleration Aging:Tensile Strength (MPa): 14 (Minimum)Ultimate Elongation (%): 500 (Minimum)After Acceleration Aging:Tensile Strength (MPa): 14 (Minimum)Ultimate Elongation (%): 400 (Minimum) | Before Acceleration Aging:Tensile Strength (MPa): 20 (Minimum)Ultimate Elongation (%): 521 (Minimum)After Acceleration Aging:Tensile Strength (MPa): 19 (Minimum)Ultimate Elongation (%): 505 (Minimum)Passed |
| ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | (Mean) AQL 2.5 | Passed |
| ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | < 2.0 mg/glove | 0.33 mg/glove, Passed |
| ISO 10993-10 Biological evaluation of medical devices — Part 10: Tests for skin irritation and skin sensitization | To determine the potential of the material under test to produce skin irritation in rabbits | Under the condition of study, testing articles are not an irritant | Under the conditions of study, the test article did not show significant evidence of causing skin sensitization in the guinea pig. (Note: Result listed under the "irritation" row in the document is the sensibility test result for the guinea pig). |
| ISO 10993-10 Biological evaluation of medical devices — Part 10: Tests for skin irritation and skin sensitization | To determine the skin sensitization potential of the material both in terms of induction and elicitation in guinea pigs. | Under the conditions of the study, the testing articles are not a sensitizer. | Under the conditions of the study the sample did not induce skin irritation. (Note: Result listed under the "sensitization" row in the document is the irritation test result). |
| ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | To evaluate the in vitro cytotoxic potential of the test item (both inner and outer surface) Extracts in L-929 mouse fibroblasts cells using elution method | Under the conditions of study, no more than grade 2 cytotoxic reaction | Mild (Grade 2) cytotoxicity reaction observed. Passed. |
Since this document describes a Class I medical device (Disposable Medical Nitrile Examination Gloves), which is a low-risk device, the requirements for its acceptance parallel those of general product testing and biocompatibility, as opposed to complex AI/ML algorithms. Therefore, the following points regarding AI/ML specific study information are not applicable to this submission:
- Sample sizes used for the test set and the data provenance: Not applicable. Testing involves physical properties and biocompatibility, not data sets for an AI model.
- 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 (e.g., tensile strength, freedom from holes) is established through standardized physical and chemical testing, not expert interpretation of AI outputs.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device is based on established material science and biological testing standards (e.g., ASTM and ISO standards) which define performance metrics for physical properties (e.g., length, width, thickness, tensile strength, elongation), chemical properties (e.g., powder residue), and biological responses (e.g., skin irritation, sensitization, cytotoxicity).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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(140 days)
The Disposable Medical Nitrile Examination Glove is 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. The subject device is non-sterile.
The provided text describes the acceptance criteria and the study conducted for a medical device: "Disposable Medical Nitrile Examination Gloves (non-sterile)." This is a Class I medical device, and the study focused on non-clinical tests to demonstrate substantial equivalence to a predicate device, rather than the types of studies typically performed for AI/ML-based diagnostic devices. Therefore, many of the requested categories are not applicable.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-5 Biological evaluation of medical devices Test for in vitro cytotoxicity | To determine the potential cytotoxicity. | Non-cytotoxic | Pass |
| ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for Systemic Toxicity | To determine the potential systemic toxicity. | Does not cause systemic toxicity. | Pass |
| ISO 10993-10 Biological evaluation on medical device Part 10: Test for Irritation and Skin Irritation | To determine the potential for irritation and skin irritation. | Non-irritant, and Non skin irritant. | Pass |
| ISO 10993-10 Biological evaluation on medical device Part 10: Test Skin Sensitization | To determine the potential skin sensitization. | Does not cause skin sensitization. | Pass |
| ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application | To test for: (1) freedom from holes (2) physical dimensions (3) Aging | (1) Shall not leak (2) For size L (mm): Width: 110 ± 10, Length: ≥ 230, Finger and palm thickness: median value ≥ 0.05 (3) After Aging: Tensile Strength: ≥ 14 MPa, Ultimate elongation: ≥400% | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of data for an AI/ML device. The tests performed are for medical gloves and involve physical and biological property assessments, not analysis of data from patients or images. The provenance of the samples (e.g., country of origin for the gloves tested) is not specified beyond the manufacturer's location (China). These were non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for the physical and biological properties of the gloves is established by standardized testing protocols (ISO, ASTM) and measurements, not by expert interpretation of data relevant to AI/ML.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As noted above, the tests are for physical and biological properties of gloves, not for AI/ML performance requiring adjudication of interpretations.
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-based diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests is based on objective measurements and established standards for material properties (e.g., tensile strength, elongation), dimensional specifications (e.g., length, width, thickness), and biocompatibility assays (e.g., cytotoxicity, irritation, sensitization, systemic toxicity).
8. The sample size for the training set
Not applicable. This device does not involve an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve an AI/ML algorithm.
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(115 days)
Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves, Non-sterile. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The document describes the acceptance criteria and study proving the device meets them for Disposable Medical Nitrile Examination Gloves (Non-Sterile) (K211075).
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASMT D6319-19 - Physical Dimensions Test (Width) | Small size: 80 ± 10 mm Medium size: 95 ± 10 mm Large size: 110 ± 10 mm Extra-large size: 120 ± 10 mm | Small size: 82mm (Minimum), 82 mm (Mean), 85 mm (Maximum) Medium size: 91 mm (Minimum), 92 mm (Mean), 93 mm (Maximum) Large size: 108 mm (Minimum), 109 mm (Mean), 110 mm (Maximum) Extra-large size: 121 mm (Minimum), 122 mm (Mean), 125 mm (Maximum) All Passed |
| ASMT D6319-19 - Physical Dimensions Test (Length) | Small size: 220 mm (Minimum) Medium size: 230 mm (Minimum) Large size: 230 mm (Minimum) Extra-large size: 230 mm (Minimum) | Small size: 232 mm (Mean), 230 mm (Minimum) Medium size: 242 mm (Mean), 240 mm (Minimum) Large size: 239 mm (Mean), 237 mm (Minimum) Extra-large size: 243 mm (Mean), 240 mm (Minimum) All Passed |
| ASMT D6319-19 - Physical Dimensions Test (Thickness) | Small size: Finger – 0.05 mm (Minimum), Palm – 0.05 mm (Minimum) Medium size: Finger – 0.05 mm (Minimum), Palm – 0.05 mm (Minimum) Large size: Finger – 0.05 mm (Minimum), Palm – 0.05 mm (Minimum) Extra-large size: Finger – 0.05 mm (Minimum), Palm – 0.05 mm (Minimum) | Small size: Finger – 0.13 mm (Mean), 0.12 mm (Minimum); Palm – 0.08 mm (Mean), 0.08 mm (Minimum) Medium size: Finger – 0.14 mm (Mean), 0.13 mm (Minimum); Palm – 0.09 mm (Mean), 0.08 mm (Minimum) Large size: Finger – 0.14 mm (Mean), 0.13 mm (Minimum); Palm – 0.09 mm (Mean), 0.09 mm (Minimum) Extra-large size: Finger – 0.14 mm (Mean), 0.13 mm (Minimum); Palm – 0.09 mm (Mean), 0.08 mm (Minimum) All Passed |
| ASMT D6319-19 - Physical Requirements Test (Tensile Strength & Elongation) | Before Aging: Tensile Strength 14 MPa (Minimum), Ultimate Elongation 500% (Minimum) After Acceleration Aging: Tensile Strength 14 MPa (Minimum), Ultimate Elongation 400% (Minimum) | Before Acceleration Aging: Tensile Strength 31 MPa (Mean), 17 MPa (Minimum); Ultimate Elongation 563% (Mean), 520% (Minimum) After Acceleration Aging: Tensile Strength 41 MPa (Mean), 28 MPa (Minimum); Ultimate Elongation 555% (Mean), 524% (Minimum) Passed |
| ASTM D6319-19 (ASTM D5151-11) - Freedom from Holes (Water Tight) | AQL 2.5 | Passed |
| ASMT D6319-19 (ASTM D6124-11) - Residual Powder | < 2.0 mg/glove | 1.02 mg/glove Passed |
| ISO 10993-10 - Skin Irritation | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 - Skin Sensitization | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. |
| ISO 10993-5 - In Vitro Cytotoxicity | Under the conditions of study non cytotoxic | Under the condition of the study, the test article showed no cytotoxicity to L-929 cells and cytotoxic level was 0. |
| ISO 10993-11:2017 - Acute Systemic Toxicity | Under the conditions of the study no systemic toxicity | Under the conditions of the study no systemic toxicity |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact "sample size" for each test in terms of the number of individual gloves or test replicates. However, it indicates that the testing was performed according to ASTM D6319-19, which specifies sampling plans and test methods for nitrile examination gloves. For example, for "Freedom from Holes," it refers to an AQL (Acceptance Quality Limit) of 2.5, which is a statistical measure related to sampling.
- Data Provenance: The testing was non-clinical. The specific country of origin for the data is not explicitly stated beyond the manufacturer being in China (Jiangsu Cherish Medical Technology Co., Ltd). The studies are retrospective in the sense that they were conducted on already manufactured gloves.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable as the document describes non-clinical performance testing of a physical medical device (gloves), not a diagnostic algorithm requiring expert ground truth or consensus. The "ground truth" is established by the standardized test methods themselves (e.g., measuring dimensions, tensile strength, presence of holes).
4. Adjudication Method for the Test Set
- This information is not applicable for the reasons stated above. Adjudication methods are typically relevant for human interpretation or AI model performance evaluation against expert-derived ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices often involving human readers or AI algorithms for interpretation, not for examination gloves.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This document evaluates a physical medical device (gloves), not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by standardized test methods and their defined specifications. These include:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-11 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-11 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10 (Biological Evaluation of Medical Devices – Tests for skin irritation and skin sensitization)
- ISO 10993-5 (Biological Evaluation of Medical Devices – Tests for in vitro cytotoxicity)
- ISO 10993-11:2017 (Biological Evaluation of Medical Devices – Tests for acute systemic toxicity)
8. Sample Size for the Training Set
- Not applicable. This device is a physical product (examination gloves), not an AI/ML model for which "training sets" are used.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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