(99 days)
The BLUE VINYL EXAMINATION GLOVES POWDER FREE is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The proposed device, BLUE VINYL EXAMINATION GLOVES POWDER FREE is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The proposed is BLUE VINYL EXAMINATION GLOVES POWDER FREE, and includes variations of different size.
The provided text is related to a 510(k) premarket notification for "BLUE VINYL EXAMINATION GLOVES POWDER FREE." This document aims to establish substantial equivalence to a predicate device, not to present a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is not applicable to this document.
This document focuses on demonstrating that the proposed medical device (examination gloves) is substantially equivalent to a legally marketed predicate device based on material, intended use, dimensions, physical properties, and biocompatibility, as per FDA regulations for Class I devices. The "bench tests" mentioned are used to verify compliance with specified ASTM and ISO standards for physical properties and freedom from holes, typical for such devices, rather than a clinical study evaluating diagnostic performance.
However, I can extract the 'acceptance criteria' as presented for the physical and biocompatibility properties of the gloves and the 'study' (bench tests and standards compliance) used to demonstrate these aspects. Please note these are not acceptance criteria in the context of an AI/algorithm study.
1. Table of Acceptance Criteria and Reported Device Performance
| Item / Test | Acceptance Criteria (Proposed Device) | Reported Device Performance |
|---|---|---|
| Physical Properties (Before Aging) | ||
| Tensile Strength | 13 MPa, min | 13 MPa, min |
| Ultimate Elongation | 400 % min | 400 % min |
| Comply with ASTM D5250 | Comply with ASTM D5250 | Comply with ASTM D5250 |
| Physical Properties (After Aging) | ||
| Tensile Strength | 13 MPa, min | 13 MPa, min |
| Ultimate Elongation | 400 % min | 400 % min |
| Comply with ASTM D5250 | Comply with ASTM D5250 | Comply with ASTM D5250 |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 (e.g., AQL for pinholes) | Be free from holes when tested in accordance with ASTM D5151 |
| Powder Content | 0.50 mg per glove | 0.50 mg per glove (meets ASTM 5250 requirements) |
| Biocompatibility - Irritation | Not an irritant (as per ISO 10993-10) | Not an irritant |
| Biocompatibility - Sensitization | Not a sensitizer (as per ISO 10993-10) | Not a sensitizer |
2. Sample size used for the test set and the data provenance:
- The document states "Bench tests were conducted to verify that the proposed device met all design specifications". Specific sample sizes for each test (e.g., for tensile strength, elongation, hole detection, powder content) are not provided in this summary, but would typically be defined within the referenced ASTM and ISO standards (e.g., ISO 2859-1 for sampling by attributes, often used for AQL testing).
- Data provenance: The tests were conducted internally by ZIBO SANYING TRADE CO., LTD or a contracted lab in China. The data would be prospective for the specific batch of gloves tested.
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):
- Not applicable in the context of an AI/algorithm study. For glove testing, "ground truth" would be the objective measurement results from standardized laboratory equipment and methods. Expert interpretation (beyond performing the test according to standard) is not typically a factor.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Glove performance tests are objective measurements, not subject to adjudicative processes like clinical assessments.
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 not an AI-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the glove's performance is based on objective physical and chemical measurements against established industry standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10). For example, a "hole" is objectively detected using the ASTM D5151 method; tensile strength is a measured value; powder content is weighed.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set.
§ 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.