(201 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands of finger to prevent contamination between patient and examiner (21CFR 880.6250)
A Powder-Free Vinyl Patient Examination Gloves'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). Our Powder-Free Vinvl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove. 80LYZ, and meets all requirement of ASTM Standard D5250-06.
The provided text is a 510(k) summary for the Shandong Binxiang Medical Products Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Non-Sterile. This document aims to demonstrate substantial equivalence to predicate devices, not primarily to prove a device's performance in terms of AI/algorithm-based criteria. Therefore, most of the requested fields related to AI/algorithm studies (sample sizes for test and training sets, ground truth establishment, expert qualifications, MRMC studies, etc.) are not applicable to this type of medical device submission.
However, I can extract the acceptance criteria and the studies performed to demonstrate equivalence for the physical and biocompatibility properties of the gloves.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance (Compliance / Result) |
|---|---|
| Physical and Dimensions Testing: | |
| ASTM D5250-06 (Dimensions) | Meets ASTM D5250-06 |
| ASTM D5250-06 (Physical Property) | Meets ASTM D5250-06 |
| Inspection Level S-2, AQL 2.5 | Meets requirements |
| Free of Pinhole: | |
| FDA 1000 ml Water Fill Test | Passed (AQL 2.5, Inspection Level 1) |
| ASTM D5151-06 (Pinhole) | Meets ASTM D5151-06 |
| Residual Powder: | |
| ASTM D6124-06 | Meets ASTM D6124-06 (less than 2mg/pc) |
| Biocompatibility: | |
| ISO 10993-10 (Primary Skin Irritation) | Passes; not irritating to skin of rabbits |
| ISO 10993-10 (Dermal Sensitization) | Passes; did not produce irritation on pigs |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test in the way an AI study would. Instead, it refers to industry standards for sampling:
- Physical and Dimensions Testing: Inspection Level S-2, AQL 2.5
- FDA 1000 ml Water Fill Test (Pinhole): AQL 2.5, Inspection Level 1
The data provenance is not explicitly stated in terms of country of origin of the raw data, but the manufacturer is Shandong Binxiang Medical Products Co., Ltd. in China, implying testing was likely conducted in China or by labs adhering to these international standards. The studies were part of a "non-clinical tests performed for Determination of Substantial Equivalence," which implies they were conducted specifically for this submission (prospective in that sense, but testing a manufactured product).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is not a study requiring expert readers to establish ground truth. The "ground truth" for glove performance is determined by the results of standardized physical and biocompatibility tests.
4. Adjudication method for the test set
Not Applicable. This is not a study requiring medical expert adjudication. Test results are based on objective measurement according to specified standards.
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 a physical medical device (gloves), not an AI/algorithm-based diagnostic or assistive system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth is established by objective measurements against recognized industry standards (ASTM, ISO, FDA requirements). For example:
- Pinhole presence is determined by the 1000 ml Water Fill Test and ASTM D5151-06.
- Residual powder is measured and compared to the ASTM D6124-06 standard (≤ 2mg/pc).
- Biocompatibility is assessed based on animal testing (rabbits for irritation, pigs for sensitization) according to ISO 10993-10.
8. The sample size for the training set
Not Applicable. This is not a machine learning or AI study.
9. How the ground truth for the training set was established
Not Applicable. This is not a machine learning or AI study.
§ 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.