(99 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 and protein claim (50 micrograms or less).
Acceptance Criteria and Device Performance Study for Non-Sterile, Powder-Free Latex Examination Gloves
This document outlines the acceptance criteria and the study conducted to demonstrate that the device, Non-Sterile, Powder-Free Latex Examination Glove with Protein Claim (50 micrograms or less), meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against established industry standards and specific tests for biocompatibility. The table below summarizes these criteria and the reported performance.
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA | DEVICE PERFORMANCE |
|---|---|---|---|
| Dimensions: overall length; width, palm | |||
| and finger thickness | ASTM D 3578-05-e1 | Adherence to ASTM D 3578-05-e1 standards | Meets |
| Tensile strength: before and after aging | ASTM D 3578-05-e1 | Adherence to ASTM D 3578-05-e1 standards | Meets |
| Ultimate elongation: before and after | |||
| aging | ASTM D 3578-05-e1 | Adherence to ASTM D 3578-05-e1 standards | Meets |
| Freedom from holes: pinholes AQL 2.5 | ASTM D 3578-05-e1 | AQL 2.5 (Acceptance Quality Limit) for pinholes | Meets |
| Powder Free Residue | ASTM D 3578-05-e1 | Adherence to ASTM D 3578-05-e1 standards | Meets |
| Protein Level | ASTM D 3578-05-e1 | 50 micrograms or less protein | Meets |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation in | ||
| Rabbits | Passes irritation test | Passes | |
| Biocompatibility: Sensitization | Guinea Pig Sensitization | Passes sensitization test | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample sizes used for each specific test within the ASTM D 3578-05-e1 standard or for the biocompatibility studies. However, the standard itself dictates sampling plans for various tests (e.g., AQL for pinholes).
Data Provenance: The studies were conducted by Siam Sempermed Corp., Ltd., an organization based in Thailand. The nature of the tests (physical properties, chemical analysis, and animal biocompatibility studies) indicates that the data is retrospective relative to the date of the 510(k) submission, meaning the tests were performed prior to the submission to demonstrate compliance. The country of origin for the data is Thailand, where the manufacturer is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For this type of device (medical gloves), the "ground truth" is not typically established by human experts in the same way as, for example, medical imaging diagnostics. Instead, the ground truth is defined by objective, measurable parameters outlined in the referenced standards (ASTM D 3578-05-e1) and established protocols for biocompatibility testing.
- ASTM D 3578-05-e1: Compliance with this standard is determined through prescribed laboratory testing methods, not by expert consensus. Therefore, no number of human experts with specific qualifications like "radiologist with 10 years of experience" would be involved in establishing this ground truth. The "experts" would be qualified laboratory technicians performing the tests according to the standard.
- Biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization): These are standardized animal tests with defined pass/fail criteria. The interpretation of results would typically be done by qualified toxicologists or veterinarians specializing in animal studies, following established protocols. The number of such individual experts is not specified but is implicit in the execution of these regulatory-driven tests.
4. Adjudication Method (for the test set)
As described above, the "ground truth" for this device's performance is determined by adherence to established, quantitative standards and prescribed test protocols. Therefore, a human "adjudication method" like 2+1 or 3+1 (common in studies involving subjective interpretation, e.g., clinical diagnosis) is not applicable here. The results of the tests are objective and directly compared against the acceptance criteria outlined in the standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study is not applicable and therefore was not done for this device. MRMC studies are used to evaluate the performance of human readers (e.g., radiologists) with and without the assistance of AI in interpreting medical images or data. This device is a physical product (examination glove), not an AI diagnostic tool, so such a study would be irrelevant.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study is not applicable for this device. This device is a physical product, not an algorithm or AI model. Therefore, there is no "algorithm-only" performance to evaluate. The studies performed are to demonstrate the physical and chemical properties of the glove itself.
7. Type of Ground Truth Used
The type of ground truth used is predominantly objective, quantitative measurements against established industry standards and regulatory biological safety protocols.
- ASTM D 3578-05-e1: Ground truth is defined by the specific values, ranges, and methodologies prescribed by this standard for dimensions, tensile strength, elongation, freedom from holes (AQL), and powder-free residue.
- Protein Level: The ground truth is the quantitative measurement of protein, with an acceptance criterion of "50 micrograms or less."
- Biocompatibility: Ground truth is established by the outcomes of validated animal tests (Primary Skin Irritation in Rabbits and Guinea Pig Sensitization) against predefined "pass" criteria for these biological responses.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable for this device. Training sets are used in machine learning and AI development to teach an algorithm to recognize patterns. Since this device is a manufactured physical product, its characteristics are determined by the manufacturing process and material properties, not by an algorithm trained on data. There is no software or AI component that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As stated above, a "training set" is not applicable for this device. Therefore, the question of how its ground truth was established is moot.
§ 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.