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510(k) Data Aggregation
(170 days)
Nitrile powder-free 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.
Nitrile powder-free patient examination, that meets all of the requirements of ASTM standard D 6319-00ae3.
The provided document describes the safety and effectiveness information for the LEGEND™ Nitrile powder-free patient examination glove. The study demonstrates the device meets acceptance criteria by comparing its performance to established ASTM standards and FDA regulations.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 6319-00ae3 | Meets |
| Palm Width (Small) | 80 +/- 10 mm | 80-90 mm |
| Palm Width (Medium) | 95 +/- 10 mm | 90-100 mm |
| Palm Width (Large) | 110 +/- 10 mm | 100-110 mm |
| Palm Width (X-Large) | 120 +/- 10 mm | 110-120 mm |
| Length (Small) | 220 mm min | 240-250 mm (all sizes) |
| Length (Medium) | 230 mm min | 240-250 mm (all sizes) |
| Length (Large) | 230 mm min | 240-250 mm (all sizes) |
| Length (X-Large) | 230 mm min | 240-250 mm (all sizes) |
| Thickness (Finger) | 0.05 mm min | 0.12 +/- 0.01 mm |
| Thickness (Palm) | 0.05 mm min | 0.12 +/- 0.01 mm |
| Physical Properties | ASTM standard D 6319-00ae3 | Meets |
| Tensile strength (Before aging) | 14 MPa min | 19.0 MPa min |
| Ultimate elongation (Before aging) | 500% min | 630% min |
| Tensile strength (After aging, 22 hours @ 100°C) | 14 MPa min | 19.0 MPa min |
| Ultimate elongation (After aging, 22 hours @ 100°C) | 400% min | 530% min |
| Freedom from pinholes | 21 CFR 800.20 | Meets (Water Tight Test performed to manufacturer's AQL under 21 CFR 820.181) |
| Powder Residual | ASTM standard D 6124-01 | Meets (<2mg/glove) |
| Biocompatibility | Primary Skin Irritation (Rabbits) | Passes (Not a Primary Skin Irritation) |
| Dermal sensitization (Guinea Pig) | Passes (Not a Dermal sensitization) |
2. Sample Size and Data Provenance
The document does not explicitly state the exact sample sizes used for each specific test (e.g., dimension, physical properties, pinholes, biocompatibility). However, it indicates that testing was conducted per recognized standards:
- Dimensions & Physical Properties: ASTM standard D 6319-00ae3.
- Freedom from Pinholes: 21 CFR 800.20 and the manufacturer's quality system acceptance criteria in 21 CFR 820.181.
- Powder Residual: ASTM standard D 6124-01.
- Biocompatibility: ISO10993-10 (specifically Primary Skin Irritation and Dermal Sensitization).
The data provenance is not explicitly stated in terms of country of origin but is implied to be from the manufacturer's internal testing as part of their premarket notification for a U.S. FDA submission. The studies were non-clinical (nonclinical submitted, reference, or relied on). The nature of the tests indicates prospective testing performed on samples of the manufactured gloves.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable. The device is a medical glove, and its performance is evaluated against objective, measurable physical, chemical, and biological standards, rather than requiring expert interpretation (e.g., radiologists, clinicians) for ground truth establishment.
4. Adjudication Method
This information is not applicable for this type of device and testing. Performance is measured against quantitative standards rather than subjective expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices where human performance is measured and compared with and without AI assistance. This device is a medical glove, and its effectiveness is determined by its physical and biocompatibility properties.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. This concept is relevant for software or AI-based devices. The LEGEND™ Nitrile powder-free patient examination glove is a physical medical device.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's performance is based on established industry standards and regulatory requirements. Specifically, these include:
- ASTM standard D 6319-00ae3 (for dimensions and physical properties)
- 21 CFR 800.20 (for freedom from pinholes/water impermeability)
- ASTM standard D 6124-01 (for powder residual)
- ISO 10993-10 (for biocompatibility - primary skin irritation and dermal sensitization)
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product, not a machine learning model, so there is no training set in the AI sense. The manufacturer would have internal quality control processes and statistical sampling plans for their manufacturing, but these are not disclosed as a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" in the context of an AI/machine learning device. The "ground truth" for the device's performance (i.e., the specifications that the device must meet) is established by the referenced national and international standards (ASTM, FDA regulations, ISO).
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