(90 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250. Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
This document is a 510(k) summary for a medical device: "Zibo Yuqun New Material Science and Technology Co. Synthetic Vinyl Patient Examination Gloves - Powder Free".
Here's an analysis of the provided text in relation to the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | |
| (Per ASTM D5250-06) | Meets requirements for Physical and Dimensions Testing (Inspection Level S-2, AQL 2.5) |
| Pinhole Detection: | |
| (Water Fill Test, FDA 1000 ml.) | Meets requirements (AQL 2.5, Inspection Level I) |
| Biocompatibility (Primary Skin Irritation): | No primary skin irritant reactions |
| Biocompatibility (Skin Sensitization/Allergic Contact Dermatitis): | No sensitization reactions |
| Powder Content: | |
| (No more than 2 mg powder per glove) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test, but "samplings" were conducted for the Water Fill Test. For Physical and Dimensions Testing, an "Inspection Level S-2, AQL 2.5" is mentioned, and for the Water Fill Test, an "AQL 2.5, Inspection Level I" is mentioned. These are statistical sampling plans, but the exact number of gloves tested is not provided in this summary.
- Data Provenance: The manufacturing company is Zibo Yuqun New Material Science and Technology Co. in Zibo, Shandong, China. It is highly probable the testing was conducted in China or by labs affiliated with the manufacturer. The summary does not specify if the testing was retrospective or prospective, but product testing for premarket notification is typically prospective to demonstrate manufacturing controls and product quality.
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 device is a patient examination glove, and the "ground truth" is established through standardized physical, chemical, and biological testing as outlined in ASTM standards and FDA guidelines, not by expert medical image interpretation. Therefore, this question is not applicable in the context of this device and study. The "experts" would be the industrial hygienists, chemists, and technicians performing the standard tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device's performance is determined by objective, standardized tests (e.g., water fill for pinholes, tensile strength, powder content), not by human interpretation or adjudication in the medical context of image analysis.
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 device is a physical product (gloves), not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and AI-related performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on:
- Pre-defined Physical Standards: Established in ASTM D5250-06 (e.g., specific dimensions, tensile strength, elongation).
- Performance Standards: Such as the maximum allowable defect rate for pinholes (AQL 2.5) and maximum powder content (2 mg per glove).
- Biocompatibility Testing: Standards for primary skin irritation and skin sensitization reactions.
These "truths" are determined through objective laboratory testing against established specifications, not through expert consensus or medical outcomes data in the way it applies to diagnostic devices.
8. The sample size for the training set
Not applicable. This is a physical product, not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established
Not applicable. As this is a physical product and not an AI/ML model, there is no "training set" or ground truth establishment relevant to an algorithm.
§ 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.