(16 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 Nitrile Examination Gloves, Blue
Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Examination Gloves, Blue, based on the provided document:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (per ASTM D 6319-00ae2) | Reported Device Performance (Implied by Certification) |
|---|---|---|
| Dimension | ||
| Length (min.) | Small: 220 mm | |
| Medium: 230 mm | ||
| Large: 230 mm | ||
| X-Large: 230 mm | Stated to meet or exceed ASTM D 6319-00ae2 | |
| Palm Width | Small: $80\pm10$ mm | |
| Medium: $95\pm10$ mm | ||
| Large: $110\pm10$ mm | ||
| X-Large: $120\pm10$ mm | Stated to meet or exceed ASTM D 6319-00ae2 | |
| Thickness | Cuff: 0.08 mm (min) | |
| Palm: 0.08 mm (min) | ||
| Finger Tip: 0.08 mm (min) | Stated to meet or exceed ASTM D 6319-00ae2 | |
| Physical Properties | ||
| Tensile Strength (Before aging) | 14 Mpa (min) | Stated to meet or exceed ASTM D 6319-00ae2 |
| Ultimate Elongation (Before aging) | 500 % (min.) | Stated to meet or exceed ASTM D 6319-00ae2 |
| Tensile Strength (After aging at 70°C 168 hrs) | 14 Mpa (min) | Stated to meet or exceed ASTM D 6319-00ae2 |
| Ultimate Elongation (After aging at 70°C 168 hrs) | 400 % (min.) | Stated to meet or exceed ASTM D 6319-00ae2 |
| Performance Requirement | ||
| Freedom from holes (AQL) | 2.5 | Meets FDA pinhole requirement (Implied AQL of 2.5 or better) |
| Dimensions (AQL) | 4 | Stated to meet or exceed ASTM D 6319-00ae2 |
| Physical Properties (AQL) | 4 | Stated to meet or exceed ASTM D 6319-00ae2 |
| Powder-free Residue | Exceeds maximum limit (Inspection Level N=5) | Stated to meet or exceed ASTM D 6319-00ae2 |
| Powder Amount | Exceeds recommended maximum limit (Inspection Level N=2) | Stated to meet or exceed ASTM D 6319-00ae2 |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the total sample size for the test set. However, it indicates specific inspection levels (e.g., "Inspection Level I" for freedom from holes, "Inspection Level S-2" for dimensions and physical properties, and specific
Nvalues for powder-free residue and powder amount). These inspection levels and AQLs (Acceptable Quality Levels) are standard in quality control for products like gloves and imply a sampling plan rather than a single fixed "test set" size. - Data Provenance: The data is generated by PT. Shamrock Manufacturing Corp. in Indonesia. The context implies it's retrospective testing conducted on finished products for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of device (medical gloves) does not typically involve "experts" establishing ground truth in the sense of medical diagnosis. The "ground truth" is established by adherence to a recognized international standard, ASTM D 6319-00ae2, which defines objective physical and performance characteristics.
- The individuals conducting the tests would be qualified laboratory technicians or quality control personnel trained in performing the specified ASTM test methods. No specific number or qualifications are provided, but competency in these tests is assumed for ISO/ASTM compliance.
4. Adjudication method for the test set:
- Not applicable in the typical sense for medical device AI/diagnostic studies. Adherence to the ASTM standard would involve objective measurements and pass/fail criteria based on quantitative data rather than expert adjudication.
- For defects like "freedom from holes," the AQL (Acceptable Quality Level) system is an adjudication method, where a certain number of defects within a sample are allowed before the lot is rejected. The AQLs are specified in the table (e.g., 2.5 for holes, 4 for dimensions and physical properties).
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 (medical gloves), not an AI diagnostic tool. Therefore, MRMC studies and human-in-the-loop performance with AI are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The "standalone" performance here refers to the glove's physical and mechanical properties as measured by standard tests, independent of human interaction (other than the testing process itself).
7. The type of ground truth used:
- The ground truth is based on objective measurements and adherence to the performance specifications outlined in the ASTM D 6319-00ae2 standard for Nitrile Examination Gloves. This includes:
- Direct physical measurements (dimensions, thickness).
- Material property tests (tensile strength, ultimate elongation) conducted in a laboratory setting.
- Defined acceptance criteria for defects (e.g., pinholes) based on AQLs.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set." The gloves are manufactured and tested against predefined standards.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device. The "ground truth" for glove characteristics is established by the well-defined, internationally recognized ASTM D 6319-00ae2 standard, which is a consensus standard developed by industry experts and updated over time.
§ 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.