(95 days)
The Biogel® Indicator™ Underglove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The Biogel® Indicator™ Underglove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.
This 510(k) summary describes the Biogel® Indicator™ Underglove, a sterile powder-free latex surgical glove. The device is classified as a Class I surgical glove (CFR 878.4461).
Here's an analysis of the provided information covering the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D3577 | Meets ASTM D3577 |
| Physical Properties | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom from Holes | Meets ASTM D3577 | Meets ASTM D3577 |
| Biocompatibility | Meets ISO 10993-1 | Meets ISO 10993-1 |
| LAL Test - final endotoxin concentration |
§ 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).