(112 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, and Vanilla meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
Here's a summary of the acceptance criteria and study information for the "Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla" based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance (Grape, Apple, Peppermint, Vanilla) |
|---|---|---|
| Dimension | ASTM D6319-10 (Min 230mm length for Size M) | Meets (240-251mm length for Size M in all scented variations) |
| Physical Properties | ASTM D6319-10 (Before Aging: Min 14 MPa Tensile Strength, Min 500% Elongation; After Aging: Min 14 MPa Tensile Strength, Min 400% Elongation) | Meets (Reported ranges consistently exceed minimums for all scented variations) |
| Freedom from holes | ASTM D6319-10 (AQL = 2.5) | Meets (0 holes found in samples for all scented variations) |
| Powder-free | ASTM D6319-10 (Max 2.0 mg/glove residual powder) | Meets (0.10 - 0.16 mg/glove residual powder for all scented variations) |
| Biocompatibility | ISO 10993-10 (Non-irritant, Non-sensitizer) | Meets (Device is non-irritant and non-sensitizer under study conditions) |
| Watertight (1000ml) | ASTM D5151-06 (2011) / ASTM D6319-10 (AQL = 2.5) | Meets (0 holes found in samples for all scented variations) |
| Length (Size M) | Min 230 mm (ASTM D6319-10) | 240-251 mm (all scented variations) |
| Palm Width (Size M) | 95 +/- 10 mm (ASTM D6319-10) | Ranges like "93-96" or "94-96" (all scented variations) |
| Thickness (Single Layer) | Min 0.05 mm (Finger, Palm) (ASTM D6319-10) | Finger: 0.10-0.14 mm; Palm: 0.07-0.09 mm (all scented variations) |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the exact sample size used for each specific test (e.g., number of gloves tested for watertightness, physical properties, etc.). It refers to meeting general ASTM standards which typically define sample sizes for such tests.
- The data provenance is Malaysia, as the manufacturing company (YTY Industry (Manjung) SDN. BHD.) is based there.
- The study appears to be prospective as it's a submission for product clearance, implying these tests were conducted on the device being submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable as the ground truth is established through adherence to standardized international and FDA-recognized test methods and specifications (ASTM D6319-10, ISO 10993-10, ASTM D5151-06, ASTM D6124-10). These standards define objective, measurable criteria, and therefore do not require expert consensus for interpretation in the same way, for example, diagnostic image analysis might.
4. Adjudication Method for the Test Set:
- None in the typical sense of expert adjudication. The tests (e.g., water leak, tensile strength, irritation) produce objective, quantitative results that are compared directly against the predefined acceptance criteria from the relevant ASTM and ISO standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human interpretation is a key component, and the AI's effect on human performance is being evaluated. This submission is for examination gloves, which do not involve human interpretation of AI output.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant. The performance evaluation is based on the physical and chemical properties of the gloves themselves.
7. Type of Ground Truth Used:
- The ground truth is based on objective, measurable criteria defined by established international and national standards for medical gloves. Specifically:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D5151-06 (2011): Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-10 (2011): Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-10: Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization (for biocompatibility).
8. Sample Size for the Training Set:
- Not applicable. This is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process of gloves is subject to Quality Management Systems (e.g., 21 CFR Part 820) which involve process control and quality assurance, not machine learning training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, for the same reasons as point 8.
§ 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.