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510(k) Data Aggregation
(75 days)
Disposable Medical Nitrile 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 Gloves. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and nonsterile (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 provided document describes the acceptance criteria and study results for "Disposable Medical Nitrile Gloves." Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 - Physical Dimensions Test | To determine the width, length, and thickness of the gloves | Width: | |
| 80 ± 10 mm (small) | |||
| 95 ± 10 mm (medium) | |||
| 110 ± 10 mm (large) | |||
| Length: (Minimum) | |||
| 220 mm (small) | |||
| 230 mm (med, large) | |||
| Thickness: (Minimum) | |||
| Finger - 0.05 mm (all sizes) | |||
| Palm - 0.05 mm (all sizes) | Passed | ||
| ASTM D6319-19 - Physical Requirements Test | To determine the tensile strength and ultimate elongation before and after acceleration aging | Before Aging: | |
| Tensile Strength: 14 MPa (Min) | |||
| Ultimate Elongation: 500% (Min) | |||
| After Aging: | |||
| Tensile Strength: 14 MPa (Min) | |||
| Ultimate Elongation: 400% (Min) | Passed | ||
| ASTM D6319-19 (ASTM D5151-11) - Detection of Holes in Medical Gloves | To determine the holes in the gloves | (Mean) AQL 2.5 | Passed |
| ASTM D6319-19 (ASTM D6124-11) - Residual Powder on Medical Gloves | To determine the residual powder in the gloves | ≤ 2.0 mg/glove | 0.1 mg/glove, Passed |
| ISO 10993-10 - Skin Irritation | To determine the potential of the material to produce skin irritation in rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 - Skin Sensitization | To determine the skin sensitization potential of the material in guinea pigs | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. |
| ISO 10993-5 - In Vitro Cytotoxicity | To evaluate the in vitro cytotoxic potential of the test item extracts in L-929 mouse fibroblasts | Under the conditions of study, no more than grade 2 cytotoxic reaction | Mild (Grade 2) cytotoxicity reaction observed. |
| ISO 10993-11:2017 - Acute Systemic Toxicity (in ICR Mice) | The test item was evaluated for acute systemic toxicity in ICR Mice | 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 sample sizes for each specific test (e.g., number of gloves tested for physical dimensions, number of animals for biocompatibility). It generally refers to the standards (e.g., ASTM D6319-19, ISO 10993 series) which inherently define sample size requirements for those tests. The data provenance is from tests conducted on the subject device, "Disposable Medical Nitrile Gloves," by Jiangsu Health-Peace Medical Technology Co. Ltd. It is retrospective in the sense that the tests were completed and reported to demonstrate compliance for premarket notification. The country of origin for the manufacturing and testing is not explicitly stated as separate from the company's address in China, but the submitting company is based in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a medical glove, and the "ground truth" for its performance is established through standardized laboratory testing (physical, chemical, and biological tests) rather than expert interpretation of medical images or clinical outcomes. The performance is objectively measured against specified criteria in established standards like ASTM and ISO.
4. Adjudication Method for the Test Set
Not applicable. As described above, the testing involves objective measurements against predefined criteria, not subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is relevant for diagnostic or interpretive devices where human readers (e.g., radiologists) interact with the device's output. Medical gloves are not diagnostic devices, and there is no "human reader" component in their performance evaluation in this context.
6. Standalone Performance Study
Yes, standalone performance studies were done. The "PERFORMANCE DATA" section and "BIO-COMPATIBILITY DATA" section detail the results of various tests conducted on the "Disposable Medical Nitrile Gloves" alone. These tests directly measure the device's characteristics against the specified acceptance criteria of recognized standards without human intervention in the loop for assessment.
7. Type of Ground Truth Used
The ground truth used for these tests is defined by established International Standards and Specifications. Specifically:
- 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 — Part 10: Tests for skin irritation and skin sensitization.
- ISO 10993-5: Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-11:2017: Biological evaluation of medical devices — Part 11: Tests for acute systemic toxicity.
These standards provide objective, measurable criteria that serve as the "ground truth" for the device's performance and safety.
8. Sample Size for the Training Set
Not applicable. This is a conventional medical device (physical product) and not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.
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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