(100 days)
The Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The Powder Free Nitrile Examination Glove Class 1 patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-10.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Nitrile Examination Glove:
The provided document is a 510(k) summary for a medical device (Powder Free Nitrile Examination Glove) and an FDA clearance letter. It details how the device meets regulatory standards rather than outlining a traditional "study" in the sense of a clinical trial for diagnostic performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) | Meets ASTM D6319-10 |
| Physical Properties | Meets ASTM D0412-98 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension) | Meets ASTM D0412-98 |
| Freedom From Pin-holes | Meets ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves) | Meets ASTM D5151-06 |
| Powder Free Residue | Meets ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves) | Meets ASTM D6124-06 |
| Dermal Sensitization | Passed - Not a Dermal Sensitization (ASTM F720-81 (Reapproved 2007) - Standard Practice for Determining the Acute Toxicity of Materials) | Passed - Not a Dermal Sensitization (ASTM F720-81 (Reapproved 2007)) |
| Primary Skin Irritation | Passed - Not a Skin Irritant (Consumer Product Safety Commission, Title 16, Chapter II, Part 1500) | Passed - Not a Skin Irritant (Consumer Product Safety Commission, Title 16, Chapter II, Part 1500) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" and a "training set" in the context of machine learning or AI. Instead, it refers to testing conducted to meet specific ASTM standards and regulatory requirements for medical devices.
- Sample Size: Not explicitly stated for each test, but implied to be sufficient to meet the statistical requirements of the respective ASTM standards.
- Data Provenance: The origin of the data is not specified beyond indicating compliance with international ASTM standards and US regulatory bodies (FDA, Consumer Product Safety Commission). The nature of the testing is "non-clinical performance data," implying lab-based assessments of physical and biocompatibility characteristics, rather than patient data. The tests are prospective in the sense that they are performed on samples of the manufactured gloves to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable in the traditional sense for this type of device and study. The "ground truth" here is objective measurement against established physical and chemical standards (ASTM specifications, CPSC regulations). Experts would be involved in performing the tests and interpreting the results according to the standard protocols, but they are not "establishing ground truth" in the way, for example, a radiologist establishes ground truth for an image-based AI system.
4. Adjudication Method for the Test Set
Not applicable. The tests are based on objective measurements and compliance with predefined thresholds in 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 (e.g., AI in radiology) where human-in-the-loop performance is being assessed. This document concerns a physical medical device (examination gloves) and its compliance with material and biocompatibility standards.
- Effect Size: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance assessment in the context of an "algorithm only" is not applicable here. This device is not an algorithm or an AI system. Its performance is inherent to its physical and chemical properties.
7. The Type of Ground Truth Used
The "ground truth" used is defined by:
- ASTM Standard Specifications: For dimensions, physical properties, freedom from pin-holes, and powder-free residue. These are quantitative and objective thresholds and methodologies described in the respective ASTM documents.
- Regulatory Guidelines/Standards: For biocompatibility tests (dermal sensitization, primary skin irritation), referencing ASTM F720 and Consumer Product Safety Commission regulations. These tests involve observing biological responses in animal models against predefined criteria for "irritant" or "sensitizer."
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI or machine learning model for this device. The manufacturing process and quality control ensure the device consistently meets the required specifications.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML model. The "ground truth," as described in point 7, is established by industry-wide recognized standards and regulatory requirements for medical gloves.
§ 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.