(88 days)
Medical nitrile examination gloves 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, Medical Nitrile Examination Gloves, is a powder free patient examination glove, it is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The device is provided in blue, purple, white and black colors. 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 medical device being discussed is "Medical Nitrile Examination Gloves" (K232576). The provided document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving clinical efficacy via extensive studies with human subjects.
Therefore, the requested information regarding multi-reader multi-case studies, human reader improvement with AI assistance, and the number of experts for ground truth establishment are not applicable as this is a physical medical device (gloves) and not an AI/software device.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The non-clinical tests conducted to demonstrate substantial equivalence are summarized in the following table. The "Results (Pass/Fail)" column directly indicates whether the device met the stated acceptance criteria.
| Test Methodology | Purpose | Acceptance Criteria | Specifics | Reported Device Performance (Pass/Fail) |
|---|---|---|---|---|
| ASTM D6319-19, ASTM D3767-03 (2020) | Physical Dimensions | Width | S: 80±10mm | |
| M: 95±10mm | ||||
| L: 110±10mm | ||||
| XL: 120±10mm | Pass | |||
| Length | S: 220mm min | |||
| M: 230mm min | ||||
| L: 230mm min | ||||
| XL: 230mm min | Pass | |||
| 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 | Pass | |||
| 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 | Non-Irritating | - | Pass |
| ISO 10993-10:2010 | Sensitization | Non-Sensitizing | - | Pass |
| ISO 10993-11:2009 | Acute Systemic Toxicity | Non-toxicity | - | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes (number of gloves or test samples) used for each specific non-clinical test (e.g., how many gloves were tested for dimensions, tensile strength, or holes). However, the tests were conducted according to recognized international and national standards (ASTM and ISO), which typically specify appropriate sampling plans and methodologies.
The data provenance is from non-clinical tests conducted by the manufacturer, Jiangsu Complete Sincerity Medical New Materials Co., Ltd., in China. The tests are retrospective in the sense that they were performed on samples of the manufactured device to demonstrate compliance with standards for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. For a physical device like examination gloves, "ground truth" is established by direct measurement and standardized testing against predefined physical and chemical properties as specified in the ASTM and ISO standards. There is no subjective interpretation by medical experts required for these types of tests.
4. Adjudication Method for the Test Set
This question is not applicable. As explained above, the assessment is based on objective, standardized tests with pass/fail criteria. There is no need for human adjudication of results in the traditional sense of medical image interpretation or clinical outcomes.
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 is not an AI/software device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is based on:
- Standardized measurement values: For dimensions (width, length, thickness), tensile strength, and elongation percentage as defined by ASTM D6319-19, ASTM D3767-03, and ASTM D412-16.
- Absence of defects/undesirable characteristics: For freedom from holes (ASTM D5151-19) and powder-free residue (ASTM D6124-06).
- Biological responses/toxicity: Absence of irritation, sensitization, and acute systemic toxicity as defined by ISO 10993-10:2010 and ISO 10993-11:2009.
These are objective, quantifiable, and internationally recognized criteria for medical gloves.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/machine learning model. There is no "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this physical device.
§ 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.