(13 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.
POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study conducted for the Powder-Free Poly-Vinyl Exam Gloves:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D 5250-00 (Vinyl Patient Examination Gloves) | Met or exceeded |
| ASTM D 5151-00 (Detection of Holes in Medical Gloves) | Met or exceeded |
| ASTM D 6124-00 (Residual Powder on Medical Gloves) | Met or exceeded |
| Bio-Burden Data | Met or exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded |
| Bio-Compatibility: Primary Skin Irritation | Met or exceeded |
2. Sample Size for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each of the tests (ASTM D 5250-00, D 5151-00, D 6124-00, Bio-Burden, Dermal Sensitization, Primary Skin Irritation). For medical device testing, these ASTM standards and biocompatibility tests typically involve specific sample size requirements.
The data provenance is also not explicitly stated. While the manufacturer is based in Taiwan, and the submitter is in the US, the location where the tests were performed is not mentioned. The document does not indicate whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
The document does not mention using experts to establish ground truth for the test set. The tests performed are objective, laboratory-based tests against established ASTM standards and biological safety criteria. These types of tests do not typically rely on subjective expert consensus for "ground truth" in the same way an imaging diagnostic algorithm might.
4. Adjudication Method for the Test Set:
An adjudication method is not applicable here. The tests are objective, with pass/fail criteria based on the specified ASTM standards and biological safety assessments. There is no subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images and the AI's impact on their performance is evaluated. The device in question is a patient examination glove, and its performance is assessed through physical and biological property testing, not diagnostic interpretation.
6. Standalone Performance Study:
Yes, a standalone study was done. The entire set of tests listed (ASTM D 5250-00, ASTM D 5151-00, ASTM D 6124-00, Bio-Burden, Dermal Sensitization, Primary Skin Irritation) represents the standalone performance evaluation of the device. These tests were conducted on the gloves themselves to demonstrate that they meet the specified standards and safety requirements. The performance reported in the table reflects the algorithm-only (device-only) performance against the established criteria.
7. Type of Ground Truth Used:
The "ground truth" for the performance evaluation is based on established industry standards and biological safety criteria.
- ASTM D 5250-00, D 5151-00, D 6124-00: These are ground truths based on published consensus standards for material properties, barrier integrity, and residual powder.
- Bio-Burden: Ground truth would be acceptable limits for microbial contamination.
- Bio-Compatibility (Dermal Sensitization, Primary Skin Irritation): Ground truth is established biological safety thresholds and responses (e.g., absence of irritation or sensitization reactions in test subjects/models).
8. Sample Size for the Training Set:
This information is not applicable/not provided. The device is a physical product (examination gloves), not an artificial intelligence or machine learning algorithm that requires a "training set" of data. The manufacturing process itself is implicitly 'trained' through quality control and process validation, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" for this type of 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.