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510(k) Data Aggregation
(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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