(62 days)
A 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.
Non-Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less)
The provided text describes a 510(k) submission for non-sterile, powder-free latex examination gloves. The study described focuses on non-clinical performance data to demonstrate substantial equivalence to a predicate device, rather than a clinical study involving human patients or complex algorithms.
Here's an analysis of the provided information, addressing each point as applicable to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-05 | Meets |
| Physical Properties | ASTM D 3578-05 | Meets |
| Freedom from pinholes | ASTM D 3578-05 | Meets |
| Powder Free Residue | ASTM D 3578-05 | Meets |
| Protein Level | ASTM D 3578-05 | Meets |
| Primary Skin Irritation | Rabbits (Biocompatibility testing) | Passes |
| Guinea Pig Sensitization | (Biocompatibility testing) | Passes |
This table indicates that the device's performance was evaluated against established ASTM (American Society for Testing and Materials) standards and biocompatibility tests.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for dimensions, pinholes, etc., or number of animals for biocompatibility). The data provenance is not detailed in terms of country of origin but implies laboratory testing. The study is non-clinical and focuses on physical and chemical properties of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of device submission (examination gloves) does not typically involve "experts" establishing a "ground truth" for a test set in the way an AI/ML medical device would. The standards (ASTM D 3578-05) themselves define the acceptable parameters, and laboratory technicians or engineers perform the measurements and assessments against these objective criteria. No information on the number or qualifications of experts for ground truth is provided, as it's not applicable in the context of this submission.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where human interpretation of data (e.g., radiology images) is involved and discrepancies need resolution. For physical and chemical testing of gloves against objective standards, an adjudication method is not relevant. The results are quantitative measurements or qualitative observations that either meet or do not meet the predefined standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is designed to assess the performance of human readers, sometimes with and without AI assistance, on a set of cases. This is a non-clinical submission for examination gloves, which does not involve human readers interpreting cases or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This submission is for a physical medical device (examination gloves), not an algorithm or AI model. Therefore, the concept of a "standalone" algorithm performance study is not applicable.
7. The Type of Ground Truth Used
The ground truth for this device is based on established objective standards. Specifically:
- ASTM D 3578-05: This standard dictates the acceptable dimensions, physical properties, freedom from pinholes, powder-free residue, and protein levels for medical examination gloves.
- Biocompatibility tests: These tests (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization) determine the biological safety of the materials in contact with skin, with "passing" results indicating acceptable biocompatibility.
8. The Sample Size for the Training Set
This concept is not applicable. "Training set" refers to data used to train an artificial intelligence or machine learning model. This submission is for a physical medical device and does not involve AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model in this submission.
§ 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.