(85 days)
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Derma Prene® Powder-Free Synthetic Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 2. Derma Prene® Powder-Free Synthetic Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Derma Prene® Powder-Free Synthetic Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. Derma Prene® Powder-Free Synthetic Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
The provided text describes the acceptance criteria and performance of the Derma Prene® Powder-Free Synthetic Surgical Gloves. It does not describe a study involving AI, human readers, or clinical outcomes data in the way a typical medical device AI study would. The acceptance criteria and performance are based on established ASTM standards for surgical gloves and biocompatibility tests.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 2 | Meets ASTM D 3577, Type 2 |
| Freedom from holes | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Freedom from holes (alternative) | Meets ASTM D 5151 | Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124 | Meets ASTM D 6124 |
| Powder-Free (residue by mass) | Not more than 2 mg residue | Meets described test in Attachment VI (implies |
§ 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).