(174 days)
The powder-free, polymer coated, sterile surgeon's glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
The Double™ Glove, a Single-Donning™ Double Glove with 2 Discrete Layers Fused at the Wrist. A Class I, Powder-free, Polymer Coated, Latex Surgeon's Glove
The provided text describes a medical device called "The Double™ Glove," a surgical glove. It outlines its characteristics and an assessment of its performance against established standards.
Here's the breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type I | Meets ASTM D 3577, Type I |
| Freedom from Holes | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Biocompatibility: | ||
| Primary Skin Irritation (Rabbits) | Pass | Pass |
| Guinea Pig Sensitization | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set explicitly. The performance data is stated as being the same as the characteristics summarized in section 6, which refers to compliance with ASTM D 3577. ASTM standards typically involve specific sampling plans for testing, but the details of those plans (e.g., number of gloves tested for holes, dimensions, etc.) are not provided in this summary.
The data provenance is not mentioned beyond the fact that testing was conducted to meet ASTM standards. There is no information about the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and therefore not provided in the document. The "ground truth" for this device is based on objective, standardized physical and biological testing against ASTM standards, not on expert consensus or interpretation of complex data by human experts.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Since the "ground truth" is based on objective measurements against ASTM standards, there is no need for an adjudication method by human experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and therefore not provided. The device is a surgical glove, and its performance is evaluated based on physical and biological properties, not on reader interpretation of medical images or data. Therefore, an MRMC study is not relevant to its assessment.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
This information is not applicable and therefore not provided. This device is not an algorithm or a device that involves human-in-the-loop performance. Its evaluation is based on its inherent physical and biological characteristics.
7. Type of Ground Truth Used
The ground truth used is based on objective, standardized measurements and tests against ASTM D 3577 requirements, primarily for physical properties (dimensions, freedom from holes, physical properties like tensile strength and elongation) and biocompatibility tests (primary skin irritation and guinea pig sensitization). This is a form of objective technical standard compliance.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. Surgical gloves are not typically "trained" using a "training set" in the context of machine learning or AI. Their design and manufacturing processes are optimized to meet a consistent set of specifications.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of this device. The "ground truth" for the device's design and manufacturing is established by the requirements of ASTM D 3577 and other relevant standards, which are developed through a consensus process involving experts in the field.
§ 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).