(86 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Powder free Latex Examination Gloves, BLACK
The document provided describes a 510(k) premarket notification for "Powder Free Latex Examination Gloves, Black" and outlines the technological characteristics and performance data used to demonstrate substantial equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D 3578-05ae2) | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| Length mm (min.) | 240 (all sizes) | 240 (all sizes) |
| Palm Width mm (Small) | - | 80 ± 10 |
| Palm Width mm (Medium) | - | 95 ± 10 |
| Palm Width mm (Large) | - | 105 ± 10 |
| Palm Width mm (X-Large) | - | 110 ± 10 |
| Thickness | ||
| Cuff mm (min) | 0.08 (all sizes) | 0.08 (all sizes) |
| Palm mm (min) | 0.10 (all sizes) | 0.10 (all sizes) |
| Finger Tip mm | 0.13 (all sizes) | 0.13 (all sizes) |
| Physical Properties (Before ageing) | ||
| Tensile Strength | 18 Mpa (min) | 18 Mpa (min) |
| Ultimate Elongation | 500 % (min) | 500 % (min) |
| Physical Properties (After ageing at 70°C 168 hrs.) | ||
| Tensile Strength | 14 Mpa (min) | 14 Mpa (min) |
| Ultimate Elongation | 500 % (min) | 500 % (min) |
| Pin holes | FDA requirement met | Meets FDA pin hole requirement |
| Labeling | Labeling claim met | Meets labeling claim |
Note: The document states "Performance data is the same as mentioned immediately above," implying the reported device performance met or exceeded the specified criteria in ASTM D 3578-05ae2.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for testing each characteristic. However, it references compliance with ASTM D 3578-05ae2 Standard, which would dictate the appropriate sampling plans for each test.
The data provenance is from PT. Maja Agung Latexindo, an Indonesian manufacturer. The study appears to be retrospective in the sense that the results are presented as having already been achieved and verified against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information about the number or qualifications of experts used to establish a "ground truth" for the test set. For medical devices like examination gloves, compliance with established industry standards (like ASTM D 3578-05ae2) and regulatory requirements (like FDA pinhole requirements) serves as the primary benchmark. These standards are developed by expert consensus within their respective fields, but individual expert adjudication of specific test results for this 510(k) submission is not described.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1, none) for the test set is mentioned. Compliance is demonstrated by meeting the quantitative specifications of the ASTM standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study was done. This type of study is typically associated with diagnostic imaging or interpretative tasks where human readers' performance is augmented by AI. For examination gloves, the performance is mechanically and physically evaluated against defined specifications, not through human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a physical medical glove, not an algorithm or an AI-powered system. The "performance" refers to the physical and mechanical properties of the glove itself.
7. The Type of Ground Truth Used
The ground truth used is primarily compliance with established industry standards and regulatory requirements, specifically:
- ASTM D 3578-05ae2 Standard: This standard defines the physical and performance requirements for medical examination gloves.
- FDA pin hole requirement: A specific regulatory requirement for glove integrity.
- Labeling claim: Verification that the product's actual performance aligns with its stated labeling.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product (latex examination gloves), not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical device like a glove.
§ 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.