(186 days)
A patient examination glove is a disposable Device,intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and cxaminer.
Class I vinyl patient examination gloves 80LYZ,powder-free,that meets all the requirements of ASTM D 5250-00.
This document is a 510(k) Pre-market Notification for a medical device, specifically Vinyl Patient Examination Gloves, Powder-Free. It outlines the device's technical characteristics and intended use but does not contain information about a study proving the device meets specific acceptance criteria related to diagnostic accuracy or AI performance.
The information provided pertains to the physical and biocompatibility properties of the gloves, comparing them to an ASTM standard. It's a regulatory submission for a Class I medical device, which typically involves demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical trial proving diagnostic performance.
Therefore, I cannot provide answers to the questions you've asked regarding acceptance criteria related to diagnostic accuracy, AI performance, sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information presented in the provided text.
The closest relevant information, regarding "acceptance criteria" for this device, would be the physical requirements outlined for the gloves to meet the ASTM D 5250-00 standard for patient examination gloves.
Here's an attempt to fill in the table with the available physical requirements and implied performance:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ASTM D 5250-00, as stated) | Reported Device Performance (ZHONGHONG) |
|---|---|
| Width Tolerance (for sizes S, M, L, XL) | ± 5 mm |
| Length (for sizes S, M, L, XL) | min 230 mm |
| Tensile Strength (Mpa, min) (Before & after accelerated aging) | 9.0 Mpa |
| Biocompatibility Data | Not explicitly stated for specific metrics, but "are conducted on the polymer coated vinyl gloves." |
| Powder-free status | Implicitly required as a "Powder-free" device |
Regarding the other questions, based on the provided text, the answers are N/A (Not Applicable) or "Information Not Provided":
- 2. Sample sized used for the test set and the data provenance: N/A. This document describes the physical properties of gloves, not a diagnostic device with a "test set" in the context of clinical performance data. The testing is for physical properties (e.g., batch testing for dimensions, tensile strength). Data provenance is from "TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD."
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth for diagnostic performance is not relevant here.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
- 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: N/A. This is not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" for this device relates to meeting physical specifications defined by the ASTM standard.
- 8. The sample size for the training set: N/A. This is not an AI/machine learning device.
- 9. How the ground truth for the training set was established: N/A.
In summary, this document describes a medical device (examination gloves) that meets industry standards for physical properties and biocompatibility, as required for its regulatory clearance. It does not involve AI, diagnostic performance, or extensive clinical study designs as typically outlined for software as a medical device (SaMD) or AI-enabled diagnostic tools.
§ 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.