(16 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.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
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 Residual | ASTM standard D 5250-06 and D6124-01 | Meets |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Biocompatibility: Dermal Sensitization | Dermal sensitization in the 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 used for the tests to evaluate "Dimension," "Physical Properties," "Freedom from pinholes," or "Powder Residual." For "Biocompatibility," it mentions "rabbits" and "guinea pig" without specifying the number of animals.
The data provenance is not explicitly stated in terms of country of origin for the individual tests, nor is it categorized as retrospective or prospective. However, the submitter's address is Tangshan, Hebei, China, which implies the testing might have been conducted in China or overseen by a Chinese entity.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The tests performed are laboratory-based and refer to established standards (ASTM, CFR, ISO), not expert interpretation of diagnostic data.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are based on objective measurements against established standards, not on expert consensus or adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a medical glove, and its performance is evaluated against physical and biocompatibility standards, not through diagnostic interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The device (the glove itself) was tested against various physical and chemical standards independently. There is no "human-in-the-loop" component for the performance of a glove in the context of these evaluations.
7. The Type of Ground Truth Used
The ground truth for the performance evaluations is based on established industry and regulatory standards. Specifically:
- ASTM standard D 5250-06
- 21 CFR 800.20
- ASTM standard D 6124-01
- ISO10993-10 (referenced for biocompatibility)
8. The Sample Size for the Training Set
This information is not applicable or not provided. This device is a passive medical device (glove), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process of the gloves might involve quality control tests, but these are not referred to as training sets in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
§ 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.