(102 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile will meet all the current specification for ASTM D6319.
The provided document describes the acceptance criteria and a study that proves a medical device, specifically "Powder Free Nitrile Examination Gloves," meets those criteria. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319 – 00a (2005) | Meets |
| Physical Properties | ASTM D 6319 – 00a (2005) | Meets |
| Freedom from pin-holes | ASTM D 5151 – 99 (2006) & ASTM D 6319 – 00a (2005) | Meets |
| Powder Free Residue | ASTM D 6124 – 06 & ASTM D 6319 – 00a (2005) | Meets |
| Biocompatibility (Dermal Sensitization) | Dermal Sensitization (as per ASTM F720-81) | Not a contact skin sensitizer |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation Test (as per 16CFR Part1500) | Not a primary skin irritant |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for each test. However, it indicates that the tests conform to ASTM standards (D6319, D5151, D6124, F720) and 16CFR Part 1500, which inherently define the sample sizes and methodologies for these tests.
- Data Provenance: The tests are conducted by the manufacturer, IDEAL QUALITY SDN. BHD., located in Malaysia. The type of study (retrospective or prospective) is not explicitly stated, but given the nature of product testing for regulatory clearance, it would be prospective testing conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes the testing of a medical glove, which relies on objective, standardized physical, chemical, and biological tests rather than subjective human interpretation of images or symptoms. Therefore, the concept of "experts establishing ground truth" in the way it applies to diagnostic AI is not applicable here. The "ground truth" is established by the defined test methods themselves and the laboratories performing these tests.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the tests are objective and based on established industry standards and regulations. There is no mention of an adjudication process among human readers or experts for the results of these physical and biological tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) where human readers interpret cases, and the AI's impact on their performance is measured. For a physical device like an examination glove, this is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable to the device described. The device is a physical product (gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used is based on objective, standardized test methods and criteria defined by:
- ASTM International standards (e.g., D6319, D5151, D6124, F720)
- U.S. Code of Federal Regulations (e.g., 16CFR Part 1500 for skin irritation).
These standards dictate the acceptable limits for various physical properties, freedom from defects, and biocompatibility, which constitute the "ground truth" for the device's performance.
8. The Sample Size for the Training Set
This question is not applicable. The device is a manufacturing product (gloves) and does not involve AI or machine learning models that require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of 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.