(627 days)
A Powdered Viny! Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powdered Vinyl Examination Gloves
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powdered Vinyl Examination Glove":
Important Note: The provided document is a 510(k) clearance letter from the FDA for a medical device (Powdered Vinyl Examination Glove). It is NOT a detailed study report. Therefore, much of the information typically found in a study report, such as specific sample sizes for training/test sets, details about ground truth establishment, or expert qualifications, will not be present in this type of document. This letter primarily confirms that the device is "substantially equivalent" to predicate devices, meaning it meets existing standards and specifications.
Based on the nature of this document and the product (examination gloves), the acceptance criteria are generally based on physical performance standards rather than diagnostic performance metrics for an AI/algorithm-driven device.
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is an examination glove, the "performance" is related to its physical properties and barrier integrity, not diagnostic accuracy. The FDA clearance implies that the device meets the applicable standards, which would include criteria like those in ASTM D5250 for vinyl examination gloves.
| Acceptance Criteria Category | Specific Acceptance Criteria (Example from relevant ASTM standards) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|---|
| Physical Dimensions | Varies by size (e.g., length, palm width, thickness) within specified tolerances. | Meets dimensional specifications for examination gloves. |
| Freedom from Holes (AQL) | Acceptable Quality Level (AQL) for pinholes (e.g., 2.5% for critical defects). | Device demonstrated an AQL for pinholes that met the standard. |
| Tensile Strength | Minimum tensile strength (e.g., before and after accelerated aging). | Meets minimum tensile strength requirements. |
| Elongation at Break | Minimum elongation at break (e.g., before and after accelerated aging). | Meets minimum elongation at break requirements. |
| Protein Content | (Less relevant for vinyl, but a criterion for latex gloves). | Not applicable for vinyl gloves. |
| Biocompatibility | Absence of skin irritation, sensitization (ISO 10993 series). | Demonstrated biocompatibility suitable for skin contact. |
| Sterility | (If claimed sterile, but examination gloves are often non-sterile). | (If non-sterile: Meets non-sterile requirements). |
Note: The 510(k) letter itself does not explicitly list these criteria or detailed results. It states that the device is "substantially equivalent" to predicate devices, which means it has been demonstrated to perform as safely and effectively as legally marketed devices under similar specifications and standards. The underlying testing would have been conducted by the manufacturer to demonstrate compliance with these standards.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the 510(k) letter. For physical testing of gloves, sample sizes are dictated by relevant ASTM/ISO standards (e.g., ANSI/ASQ Z1.4 for AQL sampling). This would typically involve taking samples from production lots (e.g., 200 gloves per lot for a specific AQL level) over a period to demonstrate consistency.
- Data Provenance: The manufacturer, Shu Tong Xinghua Company, Limited (China), would have conducted the tests. The data would be prospective in the sense that the testing is performed on manufactured lots of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable in the context of an examination glove's functional performance where "ground truth" refers to diagnostic accuracy. The "ground truth" for glove testing is derived from standardized laboratory measurements (e.g., water leak tests for pinholes, mechanical testers for tensile strength).
- The "experts" involved would be qualified laboratory technicians and quality control personnel, trained in performing the specific ASTM/ISO tests. Their qualifications would involve training in laboratory procedures, quality assurance, and potentially relevant engineering or scientific degrees.
4. Adjudication Method for the Test Set:
- Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., medical image reading) where disagreement among experts might occur. Glove testing involves objective physical measurements that have established pass/fail criteria.
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 (examination glove), not an AI-driven diagnostic or interpretative system. Therefore, no MRMC study, AI assistance, or human reader improvement metrics are relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a physical product, not an algorithm, so "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used:
- The "ground truth" for examination gloves is based on objective physical and chemical measurements against established national and international standards (e.g., ASTM D5250, D6319 for synthetic gloves, ISO 10993 for biocompatibility). Examples include:
- Direct measurement: Glove dimensions (length, width, thickness).
- Water leak test: For detection of pinholes.
- Mechanical testing: Tensile strength and elongation at break.
- Chemical analysis: For material composition and potential leachables.
- Biocompatibility testing: In-vitro and/or in-vivo tests for irritation and sensitization.
8. The Sample Size for the Training Set:
- Not applicable in the AI sense. For manufactured goods, the "training set" could be loosely analogous to the data collected during product development and early manufacturing runs to refine the production process and ensure consistency. However, sample sizes for such internal validation are not typically disclosed in 510(k) clearances and are part of the manufacturer's internal quality system documentation.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable in the AI sense. Ground truth for manufacturing processes is established through adherence to engineering specifications, material standards, and quality control procedures. Any "training" of a manufacturing process would involve iterative testing and refinement based on the measurable outcomes of the physical tests mentioned in point 7.
§ 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.