(95 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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00"4.
The provided text describes the acceptance criteria and performance of a medical device, specifically Powdered Vinyl Patient Examination Gloves, Clear (Non-colored). It relies on non-clinical testing rather than clinical studies involving human patients or complex algorithms.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension | ASTM standard D 5250-00e4 | Meets ASTM standard D 5250-00e4 requirements | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets ASTM standard D 5250-00e4 requirements | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets 21 CFR 800.20 requirements (waterlearly cest on pinhole AQL) | Meets |
| Powder Amount | ASTM standard D 5250-00e4 | Meets ASTM standard D 5250-00e4 requirements | Meets |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO10993-10) | Passes, Not a Primary Skin Irritation | Passes, Not a Primary Skin Irritation |
| Dermal sensitization in the guinea pig (ISO10993-10) | Passes, Not a Dermal sensitization | Passes, Not a Dermal sensitization |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the tests performed (e.g., number of gloves tested for pinholes, or number of animals for biocompatibility).
The data provenance is from non-clinical tests performed by the manufacturer (Tangshan Luxiong Plastic Products Co.,Ltd) to ensure compliance with established standards (ASTM, CFR, ISO). It is retrospective in the sense that the tests were performed on the manufactured product to demonstrate its characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this device. The "ground truth" for these performance criteria is established by objective engineering and biocompatibility standards (ASTM, CFR, ISO), not by expert human interpretation. The outcomes are binary (pass/fail) or quantitative measurements compared against predefined thresholds.
4. Adjudication Method for the Test Set
Not applicable. As described above, the assessments are based on objective measurement against established standards, not on human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or algorithms that human readers interpret. This device is a patient examination glove, and its effectiveness is determined by its physical and biological properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software. It is a physical medical device (gloves).
7. The Type of Ground Truth Used
The "ground truth" for this device is based on established objective laboratory test methods and standardized metrics as defined by:
- ASTM standard D 5250-00e4 (for dimensions, physical properties, powder amount)
- 21 CFR 800.20 (for freedom from pinholes)
- ISO10993-10 (for biocompatibility testing - primary skin irritation and dermal sensitization)
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device. Training sets are used for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, this question is not relevant.
§ 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.