(220 days)
Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder).
Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning.
The characteristics are summarized below compared to ASTM and ISO standards to the predicate device:
Characteristic: Dimensions, Standard: meets ASTM D 3577-06,
Characteristic: Physical Properties, Standard: meets ASTM D 3577-06,
Characteristic: Freedom from Holes, Standard: meets ASTM D 3577-06,
Characteristic: Biocompatibility, Standard: meets ISO10993-5/-10
Characteristic: Sterilization Validation, Standard: meets ISO11137
The acceptance criteria and device performance are described below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3577-06 | Meets ASTM D 3577-06 |
| Physical Properties | ASTM D 3577-06 | Meets ASTM D 3577-06 |
| Freedom from Holes | ASTM D 3577-06 | Meets ASTM D 3577-06 |
| Biocompatibility | ISO10993-5/-10 | Meets ISO10993-5/-10 |
| Sterilization Validation | ISO11137 | Meets ISO11137 |
| Powder content (Powder-Free Gloves) | No more than 2mg powder | No more than 2mg powder |
| Extractable protein (Powder-Free Gloves) | No more than 50ug/dm2 | No more than 50ug/dm2 |
| Powder content (Powdered Gloves) | No more than 120mg powder | No more than 120mg powder |
| Extractable protein (Powdered Gloves) | No more than 120ug/dm2 | No more than 120ug/dm2 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for each specific test (e.g., dimensions, physical properties). It indicates that the device characteristics were "summarized below compared to ASTM and ISO standards." This implies that the testing was conducted in accordance with the methodologies and sample sizes specified within those respective standards.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these tests (compliance with manufacturing and safety standards), it's highly likely they were prospective tests conducted on manufactured glove samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. For device testing against technical standards like ASTM and ISO, "ground truth" is established by the specifications defined in those standards, and the assessment is typically performed by trained technicians or laboratory personnel rather than clinical "experts" in the context of medical image analysis or disease diagnosis.
4. Adjudication Method for the Test Set:
This information is not provided. For standardized testing, adjudication in the sense of expert consensus on ambiguous cases is generally not applicable; rather, measurements are taken and compared directly against specified tolerances within the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:
This type of study was not applicable and therefore not conducted. The device in question is surgical gloves, a barrier device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
This type of study was not applicable and therefore not conducted. The device is a physical barrier device, not an algorithm or software.
7. The Type of Ground Truth Used:
The ground truth used for performance evaluation is derived from established industry standards and specifications. Specifically:
- ASTM D 3577-06: Standard Specification for Rubber Surgical Gloves. This standard dictates requirements for dimensions, physical properties (e.g., tensile strength, elongation), and freedom from holes.
- ISO 10993-5/-10: Biological evaluation of medical devices. Part 5 addresses tests for in vitro cytotoxicity, and Part 10 addresses tests for irritation and skin sensitization.
- ISO 11137: Sterilization of health care products — Radiation. This standard specifies requirements for the development, validation, and routine control of a sterilization process.
- Specific limits for powder and extractable protein content: These are direct measurements compared against specified maximum thresholds.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical product (surgical gloves), not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as above (not an AI model).
§ 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).