(177 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using neoprene synthetic polymer and are coated with nitrile coating and is yellow in color.
The glove 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.
The provided document describes the acceptance criteria and the study for "Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)." This is a medical device, specifically a surgical glove, and the study focuses on its physical properties, biocompatibility, and resistance to chemotherapy drug permeation. There is no AI component mentioned in this documentation, therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training) are not applicable.
Here's the breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against various standards, primarily ASTM D3577 for surgical gloves and ASTM D6978 for chemotherapy drug permeation.
| Characteristic | Acceptance Criteria (Standard/Requirement) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Primary Skin Irritation | ISO 10993-10 Guidance | Non-Irritating, under the conditions of the study |
| Guinea Pig Maximization (Sensitization) | ISO 10993-10 Guidance | Non-sensitizing, under the conditions of the study |
| Physical Characteristics | ||
| Dimensions | ASTM D3577 requirements | Meets requirements |
| Physical Properties | ASTM D3577 requirements for synthetic surgical gloves | Meets requirements |
| Freedom from Holes | 21 CFR 800.20 & ASTM D3577 requirements of AQL 1.5; ASTM D 5151 test method | 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; ASTM D6124 test method | 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).