(272 days)
Powder free 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.
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
The provided text describes the regulatory submission for Powder Free Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information:
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 (Waterleak test on pinhole AQL) | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-06 | <2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO10993-10) | Passes (Not a Primary Skin Irritation) |
| Dermal sensitization in the guinea pig (ISO10993-10) | Passes (Not a Dermal sensitization) |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" and a specific sample size for each test. Instead, it refers to the standards themselves (e.g., ASTM D 5250-06, 21 CFR 800.20, D6124-06, ISO10993-10), implying that the testing was conducted according to the sampling plans and methodologies outlined in those standards.
- Sample Size: Not explicitly stated as a single number for a "test set." The sample sizes would be those prescribed by the referenced ASTM and ISO standards for each specific test (e.g., for pinhole testing, physical properties, biocompatibility studies).
- Data Provenance: The document indicates that the submitter is HEBEI TENGDA PLASTIC CO., LTD from SHIJIAZHUANG, CHINA. The testing was conducted by or on behalf of this company to demonstrate compliance with the relevant standards. The data is retrospective in the sense that the tests were performed on finished products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for patient examination gloves is established by objective physical and chemical testing against defined standards. It does not involve expert consensus on interpretations like medical images.
4. Adjudication method for the test set
This information is not applicable. Adjudication refers to processes for resolving disagreements in expert opinions, typically in diagnostic or interpretative studies. For glove testing, the results are quantitative or pass/fail based on objective measurements against predefined acceptance criteria from standards.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. Patient examination gloves are physical barriers and do not involve such interpretative tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical product (gloves), not an algorithm or an AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used
The "ground truth" is defined by objective physical and chemical measurements performed in accordance with recognized international and national standards:
- ASTM standard D 5250-06: For dimensions and physical properties.
- 21 CFR 800.20: For freedom from pinholes (waterleak test).
- ASTM standard D 6124-06: For powder residual.
- ISO10993-10: For biocompatibility (primary skin irritation and dermal sensitization tests).
The "ground truth" is whether the glove samples objectively meet the specified quantitative and qualitative criteria defined by these standards.
8. The sample size for the training set
This information is not applicable. This submission is for a physical medical device (gloves), not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8. There is no training set for a physical device like examination gloves.
§ 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.