(256 days)
The Examination Glove is "a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner". (21CFR 880.6250)
Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The Natural rubber Is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for medical treatment. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D3578-95 and ASTM D5151-92.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Specification | Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|---|
| Non-Clinical Tests | ||
| Water Tightness | ASTM D3578-95 | Conforms to ASTM D5151-92 |
| Tensile Properties | ASTM D3578-95 | Conforms to ASTM D3578-95 |
| Clinical/Safety Tests | ||
| Rabbit Irritation | (Implicitly "Passes") | Passes |
| Guinea Pig Sensitization | (Implicitly "Passes") | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical or clinical tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The tests performed are standardized and do not involve "experts" in the sense of medical professionals establishing a ground truth for a diagnostic task.
4. Adjudication Method
This is not applicable as the tests are for material and safety properties, not for diagnostic performance requiring adjudication of interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or mentioned. This device is a medical glove, not a diagnostic imaging or AI device that would typically undergo such a study.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This is a physical medical device (examination glove), not an algorithm or AI software.
7. Type of Ground Truth Used
- For Non-Clinical Tests (Water Tightness, Tensile Properties): The "ground truth" is defined by the performance standards outlined in the ASTM specifications (ASTM D3578-95 and ASTM D5151-92). The device's physical properties are measured against these established engineering standards.
- For Clinical/Safety Tests (Rabbit Irritation, Guinea Pig Sensitization): The "ground truth" is based on established protocols for assessing biological reactivity/safety for medical devices, where a "Passes" outcome indicates that the device did not elicit an undesirable inflammatory or allergic response as per the test's criteria.
8. Sample Size for the Training Set
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
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.