(103 days)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using polyisoprene, which is a synthetic rubber latex, and is brown in color. The glove is coated with hydrogel polymer coating.
The gloves are manufactured using molds that feature anti-slip finish, 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 document describes the acceptance criteria and study for the Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating. This is a medical device, and the study focuses on its physical and biological performance against established standards rather than artificial intelligence or diagnostic capabilities. Therefore, some of the requested information regarding AI-specific elements (like human reader improvement with AI, ground truth for training sets, etc.) is not applicable.
Here's the information extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/Guidance) | Reported Device Performance (New Device) |
|---|---|---|
| Biocompatibility: | ||
| Primary Skin Irritation | ISO 10993-10 | Non-Irritating, under the conditions of the study |
| Guinea Pig Maximization | ISO 10993-10 | Non-sensitizing, under the conditions of the study |
| Physical Characteristics: | ||
| Dimensions | ASTM D3577 | Meets requirements |
| Physical Properties | ASTM D3577 | Meets requirements for synthetic surgical gloves |
| Freedom from Holes | 21 CFR 800.20 & ASTM D3577 requirements of AQL 1.5 | Tested in accordance with ASTM D 5151 and meets 21CFR 800.20 & ASTM D3577 requirements of AQL 1.5 |
| Powder Residual | ASTM D3577, ≤2.0 mg/glove for "Powder-Free" designation | Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577. 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).