(85 days)
Synguard Nitrile Exam 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.
The proposed device is a powder free medical glove. The device is blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in four sizes, which are S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
The provided document describes the acceptance criteria and study results for the "Synguard Nitrile Exam Glove".
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19, ASTM D3767-03 (2020) | Physical Dimensions | Width: S: 84±5mm, M: 94±5mm, L: 110±5mm, XL: 120±5mm | |
| Length: S: 230mm, M: 230mm, L: 240mm, XL: 240mm | |||
| Thickness: Palm: 0.05mm min, Finger: 0.05mm min | Pass | ||
| ASTM D6319-19, ASTM D412-16 | Physical Properties | Before Aging: Tensile Strength: 14MPa min, Ultimate Elongation: 500% min | |
| After Aging: Tensile Strength: 14MPa min, Ultimate Elongation: 400% min | Pass | ||
| ASTM D5151-19 | Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 | Pass |
| ASTM D6124-06 | Powder free residue | Less than 2mg per glove | Pass |
| ISO 10993-10:2010 | Irritation | The polar and nonpolar device extracts did not cause an irritation response in the animal model. | Pass |
| ISO 10993-10:2010 | Sensitization | The polar and nonpolar device extracts did not cause a sensitizing response in the animal model. | Pass |
| ISO 10993-11:2009 | Systemic Toxicity | The polar and nonpolar device extracts did not cause a systemic toxicity response in the animal model. | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test. However, it indicates that "non-clinical tests were conducted to verify that the performance of the proposed device met all design specifications of the applicable and current standards." These tests were likely conducted on samples of the Synguard Nitrile Exam Glove. The data provenance is implied to be from laboratory testing according to international standards (ASTM and ISO).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The tests performed are non-clinical, laboratory-based tests comparing physical and chemical properties to established industrial standards (ASTM, ISO), not involving human expert interpretation of results for ground truth.
4. Adjudication method for the test set
This information is not applicable as the tests are objective laboratory measurements against defined standards, not subjective interpretations requiring adjudication.
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 examination glove, which does not involve AI or human readers for diagnostic interpretation.
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 examination glove, which is a physical product and does not involve algorithms or AI performance.
7. The type of ground truth used
The "ground truth" for the performance of the Synguard Nitrile Exam Glove is based on adherence to established international industrial standards and specifications. These include:
- ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-19: Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D3767-03 (2020): Standard Practice for Rubber-Measurement of Dimensions
- ASTM D412-16: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D6124-06 (Reapproved 2017): Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10:2010: Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
- ISO 10993-11:2009: Biological evaluation of medical devices-Part 11: Tests for systemic toxicity
These standards define the acceptable ranges and performance criteria for the physical, chemical, and biological properties of examination gloves.
8. The sample size for the training set
This information is not applicable. As a physical medical device (examination glove), there is no 'training set' in the context of machine learning or AI models. The device's manufacturing processes and quality control procedures are engineered to meet the aforementioned standards.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons mentioned in point 8.
§ 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.