(267 days)
A surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is a sterile latex powder-free surgical glove that is formulated using natural rubber latex and is brown in color. The glove is coated with hydrogel polymer coating. The glove is manufactured using molds that feature an independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only. This glove is suitable for use as a specialty surgical glove intended for orthopedic procedures or other procedures where a thicker barrier may be desired such as trauma and reconstructive surgery.
The provided document describes the predicate device and the performance data that supports substantial equivalence for the "Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating." This is a medical device approval summary, and as such, it focuses on non-clinical tests to demonstrate performance in line with existing standards for gloves, rather than a study for an AI-powered diagnostic device.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set size, ground truth for training set) are not applicable to this type of device and submission.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (New Device) |
|---|---|---|
| Biocompatibility (Overall) | ISO 10993-1 | Meets requirements |
| Primary Skin Irritation | ISO 10993-10 | Pass (Under conditions of the study, gloves are non-irritating.) |
| Guinea Pig Maximization | ISO 10993-10 | Pass (Under the conditions of the study, gloves do not display any potential for sensitization.) |
| Dimensions | ASTM D3577 | Meets requirements |
| Physical Properties | ASTM D3577 | Meets requirements for rubber surgical gloves |
| Freedom from Holes | 21 CFR 800.20 & ASTM D3577 | Meets requirements (Tested in accordance with ASTM D5151 with acceptable results) |
| Powder Residual | ASTM D3577 | Meets requirements of ≤ 2.0 mg/glove for "Powder-Free" designation (Results generated values |
§ 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).