(105 days)
A medical glove is a disposable device intended for medical purposes that is worn on hand of the examiner's hand to prevent contamination between the patient and the 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 five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The difference between each size is just in the dimension. The proposed device is provided non-sterile.
The provided text describes the acceptance criteria and the study conducted for "Medical Examination Gloves" (K213168). However, it does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study, but rather the performance testing for a physical medical device (gloves). Therefore, many of the requested points related to AI/ML device testing will not be applicable and will be marked as "N/A".
Here's the breakdown of the acceptance criteria and study as described in the document:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D6319-19, ASTM D3767-03 (2020) | Physical Dimensions | Width: | |
| XS: 70±10mm | |||
| S: 80±10mm | |||
| M: 95±10mm | |||
| L: 110±10mm | |||
| XL: 120±10mm | |||
| Length: | |||
| XS: 220mm min | |||
| S: 220mm min | |||
| M: 230mm min | |||
| L: 230mm min | |||
| XL: 230mm min | |||
| 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 | Non-Irritating | Pass |
| ISO 10993-10:2010 | Sensitization | Non-Sensitizing | Pass |
| ISO 10993-11:2009 | System toxicity | Non-toxicity | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes for each physical test. It merely states that "Non clinical tests were conducted to verify that the proposed device met all design specifications and acceptance criteria in the test methodology and the standards." The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated, but given that the manufacturer is in China and the testing is for FDA clearance, it's reasonable to infer the tests were conducted or overseen by the manufacturer. The tests are prospective in nature, as they are performed on the device to prove its compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is a physical medical glove undergoing performance testing against standardized physical and biocompatibility criteria, not an AI/ML device requiring expert ground truth for image/data interpretation. Ground truth is established by the test methodologies themselves (e.g., measuring dimensions, tensile strength, etc.).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for subjective assessments or disagreements in interpretative tasks, which do not apply to the objective physical and chemical testing of medical gloves.
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
No. This study is for a physical medical glove, not an AI/ML device. Therefore, an MRMC comparative effectiveness study was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is derived from standardized test methodologies and specifications (e.g., ASTM D6319-19 for dimensions and physical properties, ASTM D5151-19 for holes, ASTM D6124-06 for powder residue, and ISO 10993-10/11 for biocompatibility). These standards define the objective measurements and criteria that the device must meet.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a 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.