(84 days)
The powder free vinyl patient examination glove, Clear (non-colored) 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. It is sold as non sterile.
Powder free vinyl patient examination gloves, clear (non-colored), non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements.
The provided text describes the acceptance criteria and the study for a medical device: "Powder Free Vinyl Patient Examination Gloves."
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Description | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Physical Property | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Free of Pinhole | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Residue Powder | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Primary Skin Irritation | Passes (ISO 10993-10) | Passes |
| Dermal Sensitization | Passes (ISO 10993-10) | Passes |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size used for each test. It states that "Tests were conducted following the recommended procedures outlined in the respective consensus standards." These consensus standards (ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, ISO 10993-10) would dictate the specific sampling plans.
The data provenance is from Wealth On (Jiangsu) Co., Ltd, located in Yancheng, Jiangsu Province, China. The study is a retrospective evaluation performed on the manufactured gloves against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. For these types of physical and biocompatibility tests on medical gloves, "ground truth" is typically established by adherence to the specifications and methods outlined in the referenced consensus standards, rather than requiring individual expert consensus. The standards themselves define what constitutes a pass or fail.
4. Adjudication Method for the Test Set:
This information is not applicable/not provided as the evaluation is based on objective measurements against engineering and material standards, not subjective assessments 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 devices that involve human interpretation of images or other data. For physical examination gloves, such a study is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
No, a standalone (algorithm-only) performance study was not done. This device is a physical product (gloves), not a software algorithm, so this type of study is not relevant.
7. The Type of Ground Truth Used:
The ground truth used for this study is based on consensus standards and laboratory testing protocols. The performance criteria are defined by established standards such as ASTM International standards (D5250-06, D5151-06, D6124-06) and ISO standards (ISO 10993-10). These standards provide the objective benchmarks for what constitutes acceptable performance for patient examination gloves.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. The device is a physical product, not an AI/ML algorithm that requires a "training set." The testing performed is to assess the manufactured product's compliance with established performance criteria.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable/not provided 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.