(69 days)
Powdered vinyl 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.
powdered vinyl patient examination gloves, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.
The provided text describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves (Light Yellow)." This is a medical device submission, specifically for patient examination gloves, which are low-risk devices. Therefore, the acceptance criteria and study design are different from what would be expected for a complex AI/ML diagnostic or prognostic device.
Here's the breakdown of the information based on your request, tailored to this type of device:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06 | Primary Skin Irritation |
| --> Dermal Sensitization | Per ISO10993-10 or equivalent (guinea pig) | Passes; Not a Dermal sensitization |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for pinholes, how many animals for biocompatibility). However, the tests are conducted according to established standards (ASTM, FDA regulations, ISO), which inherently define the sampling methods and acceptance levels.
- Provenance: This is a physical product (gloves), not data in the sense of patient records or images. The "data" provenance refers to the testing conducted on the manufactured gloves. There is no mention of country of origin for the data (testing results), but the manufacturer is based in China. The tests are non-clinical and would be considered prospective for the specific batch of gloves tested to support the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of this device. "Ground truth" usually refers to diagnostic accuracy in complex medical imaging or clinical decision-making. For these gloves, "ground truth" is established by direct measurement against a defined engineering or biological standard. For example, a pinhole is objectively present or absent based on a waterleak test. Biocompatibility tests are performed by trained laboratory personnel following established protocols, not by "experts" establishing a subjective ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. The tests are objective measurements against defined criteria (e.g., glove dimensions, force at break, waterleak test for pinholes, standardized biological assays). There is no subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. MRMC studies are used for evaluating diagnostic performance of imaging devices or algorithms with human readers. This device is a medical glove, not a diagnostic tool requiring interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (glove), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- The "ground truth" for the acceptance criteria is defined by industry standards (ASTM D 5250-06, ASTM D6124-01) and regulatory requirements (21 CFR 800.20, ISO10993-10). This includes:
- Engineering specifications: For dimensions, physical properties (tensile strength, elongation), and powder amount.
- Physical test results: For freedom from pinholes (waterleak test).
- Biological assay results: For biocompatibility (primary skin irritation and dermal sensitization tests in animal models).
8. The Sample Size for the Training Set:
- Not applicable. This is a manufactured product, without a "training set" in the AI/ML sense. The manufacturing process uses quality control, and the design itself is based on general engineering principles for glove production, not machine learning.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" for this device. The design specifications and manufacturing process are established based on the requirements of the ASTM standards and FDA regulations, informed by decades of glove manufacturing and material science.
§ 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.