(85 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 Disposable Medical Nitrile Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D6319 - 19, Standard Specification for Nitrile Examination Gloves for Medical Application. Disposable Medical Nitrile Examination Gloves are mainly composed of nitrile latex. It is mainly suitable for hand protection during medical examination. These gloves are powder free. The proposed device(s) are orange color and sold non-sterile and are intended to be single-use, disposable devices.
The provided document is a 510(k) Premarket Notification for Disposable Medical Nitrile Examination Gloves. This type of medical device falls under Class I, reserved, and is a non-AI/ML device. Therefore, the detailed acceptance criteria and study design elements typically associated with AI/ML device performance (such as sample size for test/training sets, expert consensus, MRMC studies, etc.) are not applicable in this context.
The document focuses on demonstrating substantial equivalence to a predicate device (K222498) through a series of bench tests and biocompatibility tests, primarily based on established ASTM and ISO standards for medical gloves.
Here's how the information provided relates to the closest equivalent of "acceptance criteria" and "proof" for this specific device:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, the "acceptance criteria" are the performance requirements set forth by relevant industry standards (ASTM, ISO). The "reported device performance" is the result of the bench tests demonstrating compliance with these standards.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| Physical Dimensions (ASTM D6319-19 Table 2): Conformity to specified length, width, and thickness ranges. | The subject device complies with the dimension requirements prescribed in ASTM D6319-19. |
| Physical Property Characteristics (ASTM D6319-19 Table 3, before and after accelerated aging): Minimum Tensile Strength and Ultimate Elongation. | Before and after accelerated aging, the subject device complies with the physical requirements specified in ASTM D6319-19 Table 3. |
| Freedom From Holes (ASTM D5151-06): No water leakage. | No water leakage is inspected. The subject device complies with the requirements specified in ASTM D5151. |
| Residual Powder (ASTM D6124-06, R2017): Less than 2 mg per glove. | Residual Powder less than 2 mg per glove. The subject device complies with the requirements specified in ASTM D6124. |
| Acute Systemic Toxicity (ISO 10993-11): No evidence of systemic toxicity from the extract. | The test article has no potential acute system toxicity on ICR mice in the extraction method. |
| Skin Irritation (ISO 10993-23: 2021): No skin irritation. | Under the experimental conditions, the test article has no skin irritation on rabbits. |
| Skin Sensitization (ISO 10993-10: 2021): No evidence of delayed dermal contact sensitization. | The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a single number (e.g., N=X gloves). The testing is generally done on samples taken from production lots to ensure consistency. The specific sample sizes for each test are typically defined within the respective ASTM/ISO standards (e.g., AQL for freedom from holes).
- Data Provenance: The device manufacturer is Hebei Titans Hongsen Medical Technology Co., Ltd. in China. The tests were performed to demonstrate compliance with international standards (ASTM, ISO). The data is generated through prospective bench testing and biological evaluation in a controlled laboratory environment.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable: For this Class I device, the "ground truth" is defined by the objective, quantifiable parameters and pass/fail criteria established in the ASTM and ISO standards for glove performance and biocompatibility. There is no need for human expert consensus on subjective interpretations, as would be the case for image-based diagnostic AI. The tests are conducted by trained technicians in accredited labs according to standardized protocols.
4. Adjudication Method for the Test Set
- Not Applicable: As the "ground truth" is based on objective measurements and predefined standard thresholds, there is no need for an adjudication method by multiple human readers. Test results are either within the acceptable range or not.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No: MRMC studies are relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This is a non-AI/ML medical glove, so such a study is not applicable.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Yes (in concept, but not an "algorithm"): The "standalone performance" for this device refers to its ability to meet the physical and biological requirements of the standards independently, without human interaction during "use" in a diagnostic or interpretive sense. The bench tests and biocompatibility tests effectively demonstrate this "standalone" performance against defined metrics.
7. The Type of Ground Truth Used
- Standard-based Physical and Chemical Properties / Biological Reactions: The ground truth is established by the specified acceptance criteria within the referenced ASTM (e.g., D6319-19 for physical properties, D5151-06 for holes, D6124-06 for residual powder) and ISO standards (e.g., ISO 10993-10 for sensitization, 10993-11 for systemic toxicity, 10993-23 for irritation) for medical examination gloves. These are objective, measurable physical properties and biological responses.
8. The Sample Size for the Training Set
- Not Applicable: This is not an AI/ML device, so there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: No training set exists for this type of device.
In summary, for medical gloves, the regulatory acceptance and "proof" of performance revolve around rigorous non-clinical bench testing and biocompatibility assessments against established international standards, rather than clinical studies or AI/ML specific performance metrics.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.