(128 days)
The examination glove is a disposuble device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50µg/dm² or Less of Water Soluble Protein)
Here's an analysis based on the provided text, outlining the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM Standard D3578 | Meets |
| Physical Properties | ASTM Standard D3578 | Meets |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151 | Meets |
| Powder Residual | ASTM Standard D6124 | Meets (values below 2mg of residual powder) |
| Protein Level | ASTM Standard D5712 | Meets (values below 50 mcg/gm) |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10 | Passes |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10 | Gloves do not display any potential for sensitization |
| Sterilization | Radiation dose of 25 kGy (implied as "Same" to predicate) | Radiation dose of 25 kGy (from predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for testing each characteristic. However, each standard (ASTM, ISO, 21 CFR) defines specific methodologies and sample sizes for their respective tests. For example, ASTM D5151 (Freedom from Pinholes) would specify a certain number of gloves to be tested.
The data provenance is not explicitly mentioned, but given the context of a 510(k) submission to the FDA, it is expected that the testing was conducted prospectively according to the listed standards. No information on country of origin for the data is provided, nor is it indicated if it's retrospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable (N/A) to this type of device (examination gloves). The "ground truth" for glove performance is established by objective measurements against harmonized standards (e.g., ASTM, ISO), not by expert consensus or interpretation of images/data. The tests are industrial and chemical, not interpretive.
4. Adjudication Method for the Test Set
This information is N/A for this device. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For objective measurements of physical, chemical, and biological properties, results are either within spec or not.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is N/A for this device. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The device in question is a physical glove, not an AI system.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is N/A for this device. A "standalone study" typically refers to the performance of an AI algorithm independent of human interaction. The device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established by objective measurements against recognized national and international standards. These standards define the acceptable range or threshold for each characteristic (e.g., minimum elongation, maximum protein level, freedom from pinholes). There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense for these performance criteria.
8. The Sample Size for the Training Set
This information is N/A for this device. The concept of a "training set" (used to train machine learning models) is not relevant to the evaluation of physical medical devices like examination gloves. Development of such gloves involves manufacturing processes and quality control, not AI model training.
9. How the Ground Truth for the Training Set Was Established
This information is N/A for this device, for the same reasons as point 8.
§ 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.