(24 days)
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 2. Elite™ Powder Free Polyurethane Synthetic Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Elite™ Powder Free Polyurethane Synthetic Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
Here's a breakdown of the acceptance criteria and study information based on the provided documents.
The document describes the regulatory submission for Elite™ Powder Free Polyurethane Synthetic Surgical Gloves. The "study" here refers to the testing performed to demonstrate that the device meets existing standards, rather than a clinical trial for efficacy against a disease.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Specification) | Reported Device Performance |
|---|---|
| ASTM D 3577 (General Requirements) | Meets ASTM D 3577 |
| ASTM D 3577, Type 2 (Physical Properties) | Meets ASTM D 3577, Type 2 |
Note: The document explicitly states that the "Elite™ Powder Free Polyurethane Synthetic Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves" and that the product "meets all of the requirements of ASTM D 3577, Type 2." These are the primary performance criteria cited.
2. Sample Size Used for the Test Set and Data Provenance
The provided document (a 510(k) summary and FDA letter) does not specify the exact sample size used for destructive physical testing or the country of origin. Regulatory submissions for devices like surgical gloves typically involve testing batches according to the ASTM standards. The data would be prospective, as it's generated specifically for the submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. For devices like surgical gloves, the "ground truth" is established by the specifications defined in recognized consensus standards (e.g., ASTM D 3577). The "experts" in this context are the committees and bodies that develop and maintain these international standards, and the testing laboratories that perform the specified tests according to documented and validated methods. It's not about expert clinical consensus on individual cases.
4. Adjudication Method for the Test Set
N/A. As mentioned above, the "ground truth" is defined by the ASTM D 3577 standard. Testing is performed according to the methods outlined in this standard, and the results are compared against the pass/fail criteria. There isn't an "adjudication method" in the sense of reconciling divergent expert opinions on a clinical outcome.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not applicable for this type of device. Surgical gloves are subject to performance testing against established physical and chemical standards, not comparative clinical effectiveness via human readers or interpreters.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This is not an AI/algorithm-driven device. Its performance is based purely on its physical and material properties.
7. The Type of Ground Truth Used
Expert Consensus (Standards): The ground truth is defined by the ASTM D 3577 standard. This standard, developed by technical experts, specifies the required dimensions, physical properties (e.g., tensile strength, elongation at break), and barrier integrity (e.g., freedom from holes) for rubber surgical gloves. Compliance with this standard indicates the device's fitness for its intended purpose.
8. The Sample Size for the Training Set
N/A. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. The gloves are manufactured and tested against predefined specifications.
9. How the Ground Truth for the Training Set Was Established
N/A. (See 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).