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510(k) Data Aggregation
(141 days)
A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The powder-free vinyl exam gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient. The powder-free vinyl exam gloves possess the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions, Physical Properties, Freedom from pinholes, Powder Free.
Here's an analysis of the provided information regarding the SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove, structured to address your request:
Acceptance Criteria and Device Performance Study for SAFESKIN BLUE ZONE Powder-Free Vinyl Exam Glove*
This submission details the safety and effectiveness of a powder-free vinyl exam glove, demonstrating its substantial equivalence to a predicate device. The primary method of proving equivalence and meeting acceptance criteria relies on compliance with established ASTM standards for patient examination gloves and ISO standards for biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Study Title | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 5250-00 ("Standard Specification for Poly(vinyl chloride) Gloves for Medical Application") | Meets ASTM D 5250-00 |
| Physical Properties | Meets ASTM D 5250-00 | Meets ASTM D 5250-00 |
| Freedom from Pinholes | Meets ASTM D 5250-00 and ASTM D 5151-99 | Meets ASTM D 5250-00 |
| Meets ASTM D 5151-99 | ||
| Powder Free | Meets ASTM D 6124-01 and ASTM D 5250-00 | Meets ASTM D 6124-01 |
| Meets ASTM D 5250-00 | ||
| Biocompatibility: | (ISO 10993, "Biological Evaluation of Medical Devices") | |
| ISO Skin Irritation Study | Part 10, "Tests for Irritation and Sensitization" (Pass/Fail) | Passed (Test Animal: Rabbit) |
| Murine Local Lymph Node Assay (LLNA) | Part 10, "Tests for Irritation and Sensitization" (Pass/Fail) | Passed (Test Animal: Mouse) |
| USP and ISO Systemic Toxicity Study Extract | Part 11, "Tests for Systemic Toxicity(ISO)" (Pass/Fail) | Passed (Test Animal: Mouse) |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly state exact sample sizes for each specific test (e.g., number of gloves tested for dimensions, pinholes, or powder). However, compliance with ASTM standards generally implies specific sampling plans and test methodologies. The data provenance is not explicitly mentioned by country of origin, but the testing was conducted by the Kimberly-Clark Corporation for submission to the US FDA. The studies are prospective in nature, as they are conducted specifically to demonstrate compliance for a new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of medical device (exam glove) does not typically involve human expert interpretation of results in the way, for example, an imaging AI would. The "ground truth" for the acceptance criteria (ASTM and ISO standards) is established by the test methods and objective measurements outlined within those standards. Therefore, no human experts as typically defined in an AI/clinical study context were used to establish the ground truth for the performance test set. Expert committees within ASTM and ISO develop and maintain these standards.
4. Adjudication Method for the Test Set
Not applicable. As described above, the acceptance criteria are based on objective measurements against established technical standards, not on subjective expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, often with or without AI assistance, to assess diagnostic accuracy or efficiency. For a patient examination glove, the efficacy is determined by its physical properties and biocompatibility, not by human interpretation of its function in a diagnostic context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm-only) performance study was not done. This device is a physical product, not a software algorithm. The performance evaluation is based on direct physical and chemical testing of the glove.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device's performance is established industry standards and objective test methods. Specifically:
- ASTM D 5250-00, ASTM D 5151-99, ASTM D 6124-01: These standards define the acceptable physical and chemical properties of patient examination gloves and provide the test methods to determine compliance.
- ISO 10993 Parts 10 and 11: These international standards define the test methods and acceptable outcomes for biological evaluation (biocompatibility) of medical devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI algorithms. The manufacturing process is subject to quality control, but there isn't a training dataset for an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a software algorithm.
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