(49 days)
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Encore Mark IV Powder Free Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 1. Encore Mark IV Powder Free Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Encore Mark IV Powder Free Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. Encore Mark IV Powder Free Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
The medical device discussed in the provided text is "Encore Mark IV Powder Free Surgical Gloves". This 510(k) summary focuses on demonstrating that the device is substantially equivalent to existing standards for surgical gloves, rather than presenting a study of its performance against acceptance criteria in a clinical setting in the way a diagnostic AI device would. Therefore, much of the requested information regarding AI device studies is not applicable.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Encore Mark IV Powder Free Surgical Gloves are based on established ASTM (American Society for Testing and Materials) standards and FDA requirements for medical gloves.
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance (Encore Mark IV Powder Free Surgical Gloves) |
|---|---|---|
| Dimensions | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 1 | Meets ASTM D 3577, Type 1 |
| Freedom from holes | Meets ASTM D 3577 | Meets ASTM D 5151 (and implicitly ASTM D 3577) |
| Powder-Free | Meets ASTM D 6124 | Not more than 2 mg residue by mass |
| Biocompatibility | ||
| Primary Skin Irritation | (Likely a Pass/Fail criterion) | Passes |
| Guinea Pig Sensitization | (Likely a Pass/Fail criterion) | Passes |
Note: The document states "Encore Mark IV Powder Free Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves," which acts as an overarching statement for many physical and dimensional properties.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the testing of the Encore Mark IV gloves against the ASTM standards. These tests are typically conducted on representative samples from manufacturing batches. The data provenance is derived from internal testing by Ansell Perry to ensure compliance with the specified ASTM standards. It's retrospective in the sense that the tests are performed on manufactured gloves to confirm they meet predefined standards. There is no information on country of origin for the data provided beyond Ansell Perry being an American company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this device. The "ground truth" for the device's performance is established by the specified ASTM standards themselves. These standards are developed by consensus among experts in the field of materials science, manufacturing, and medical device regulation. The individual who performs the tests to determine compliance would be a trained laboratory technician or engineer, adhering to the methodologies outlined in the ASTM standards.
4. Adjudication Method for the Test Set
This is not applicable as the "acceptance criteria" are quantitative measurements against an established standard (e.g., maximum residue, minimum tensile strength, etc.) rather than subjective expert consensus. The results are typically pass/fail based on direct measurement and comparison to the standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for comparing the diagnostic performance of human readers, potentially with and without AI assistance, on a set of cases. This device is a surgical glove, which is a physical product, not a diagnostic tool where human interpretation is involved in its function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This concept is not applicable. There is no algorithm or AI component in the Encore Mark IV Powder Free Surgical Gloves.
7. The Type of Ground Truth Used
The ground truth used for evaluating this device's performance against its acceptance criteria is established industry and regulatory standards. Specifically:
- ASTM D 3577: Standard Specification for Rubber Surgical Gloves.
- ASTM D 5151: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D 6124: Standard Test Method for Residual Powder on Medical Gloves.
- Biocompatibility tests (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization) follow established biological evaluation methods for medical devices.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of a physical medical device like a surgical glove. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this product.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).