(115 days)
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
The provided documents describe the performance of "Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Examination Glove, Pink". This is a medical device classified as a Class I, 21 CFR 880.6250, Polymer Patient Examination Glove, 80 LZA.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Applicable FDA-Recognized Standards | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319-00a (2005)e1 | Conforms to standard | Meets |
| Physical Properties | ASTM D 6319-00a (2005)e1 | Conforms to standard | Meets |
| Freedom from holes | ASTM D 6319-00a (2005)e1 | Conforms to standard | Meets |
| Residual Powder Test | ASTM D 6319-00a (2005)e1, ASTM D6124-06 | Conforms to standard | Meets |
| Primary Skin Irritation and Sensitization | ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3 | Conforms to standards | Meets |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. However, the tests are non-clinical (laboratory/material characteristic tests) and typically involve statistical sampling based on the specific ASTM or ISO standard requirements for batch testing. The data provenance is implied to be from the manufacturer's testing in support of their 510(k) submission, likely performed in China (country of origin of the manufacturer) and provided to the FDA. The tests are retrospective, meaning they were conducted on already manufactured devices.
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 as the evaluation of exam gloves against ASTM and ISO standards involves objective laboratory measurements and tests, not subjective interpretation by human experts to establish ground truth. The "ground truth" is the established technical specification defined by the standards themselves.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 refer to a process of resolving discrepancies among multiple human readers for subjective assessments (e.g., medical image interpretation). For the physical and chemical tests conducted on examination gloves, the results are quantitative or qualitative assessments against defined criteria, not 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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a disposable examination glove, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done. This question is also relevant for AI algorithms. The performance of the examination glove is measured by its physical and chemical properties and biocompatibility, not by an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is established by conformance to recognized industry standards (ASTM D 6319-00a (2005)e1, ASTM D6124-06, ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3). These standards define the acceptable range or limits for dimensions, strength, freedom from holes, residual powder, and biological response (skin irritation/sensitization).
8. The sample size for the training set
This information is not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as 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.