(47 days)
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These latex gloves contain 50 micrograms or less of water extractable protein per gram.
Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. These latex gloves contain 50 micrograms or less of water extractable protein per gram.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less)
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 2 | Meets ASTM D 3577, Type 2 |
| Freedom from Holes | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Meets ASTM D 5151 | Meets ASTM D 5151 | |
| Powder-Free | Meets ASTM D 6124 | Meets ASTM D 6124 |
| Powder content ≤ 2 mg per glove | Powder content ≤ 2 mg per glove | |
| Biocompatibility | Non-Toxic at 24 hours | Non-Toxic at 24 hours |
| FHSA Skin Irritation | Passes | Passes |
| ISO Maximization Sensitization | Passes | Passes |
| Cytotoxicity | Passes | Passes |
| Protein Label Claim | Contains 50 micrograms or less of total water extractable protein per gram | Contains 50 micrograms or less of total water extractable protein per gram |
| Protein Analysis Method | Meets ASTM D 5712-99 | Meets ASTM D 5712-99 |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not explicitly state the sample size used for the non-clinical tests. It refers to these as "performance test data of the non-clinical tests."
The data provenance is not specified (e.g., country of origin). Since it refers to widely used ASTM and ISO standards, it's likely that the tests were conducted in a laboratory setting adhering to these international standards. The study appears to be retrospective in the sense that the data being presented are from tests already performed to demonstrate compliance with existing standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts in the context of establishing ground truth for the device's performance against the listed standards. The acceptance criteria are based on established industry standards (ASTM, ISO), which inherently represent a consensus of expert knowledge in glove manufacturing and medical device safety. The "ground truth" for these tests is the quantitative measurement or qualitative observation against the predefined parameters of these standards.
4. Adjudication Method for the Test Set:
There is no explicit adjudication method described. Compliance with the standards would typically involve laboratory analysis and direct measurement against the specified thresholds. Discrepancies, if any, would be resolved by re-testing or investigation, but no formal expert adjudication process (like 2+1, 3+1) is mentioned or typically required for this type of product testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. The device is a sterile latex surgical glove. MRMC studies are typically used for diagnostic or screening devices that involve human interpretation of images or other data. This product does not involve such a human-in-the-loop diagnostic process.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
Yes, in essence. The performance tests described (Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Biocompatibility components, Protein Label Claim) are all standalone performance evaluations of the glove itself. These tests are conducted without any human-in-the-loop assistance in decision-making related to the device's function as a diagnostic or analytical tool. The human element would be in conducting the tests and recording results, but not in interpreting the "output" of the device for a medical diagnosis.
7. The Type of Ground Truth Used:
The ground truth used is primarily established industry standards and regulatory requirements. This includes:
- ASTM (American Society for Testing and Materials) standards: D 3577 (Dimensions, Physical Properties, Freedom from Holes), D 5151 (Freedom from Holes), D 6124 (Powder-Free), D 5712-99 (Protein Analysis).
- ISO (International Organization for Standardization) standards: for Biocompatibility (Maximization Sensitization Study).
- FHSA (Federal Hazardous Substances Act) standards: for Biocompatibility (Skin Irritation Study).
- FDA hole requirements: mentioned as a general compliance point.
8. The Sample Size for the Training Set:
This question is not applicable to this type of device. The device is a physical medical product (surgical glove), not an AI/ML algorithm or a device that requires a "training set" in the context of machine learning. The term "training set" is relevant for AI models, not for characterizing a physical product like a glove.
9. How the Ground Truth for the Training Set was Established:
This question is not applicable for the same reason as point 8.
§ 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).