(105 days)
The Biogel Orthopedic Surgeon's Glove 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 Orthodepic Surgical Glove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.
The provided document is a 510(k) summary and FDA clearance letter for a medical device: the Biogel Orthopedic Surgical Glove. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel clinical effectiveness with extensive studies. As such, many of the requested elements (like sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, or training set details) are not relevant or typically included in such filings for this class of device.
Here's a breakdown of the available information:
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 (Endotoxin) |
§ 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).