(34 days)
The Biogel® OrthoPro® Brown Surgical 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 proposed device, the Biogel® OrthoPro® Brown Surgical Glove is manufactured of natural rubber latex colored with brown nigmentation. The Biogel® OrthoPro® Brown Surgical Glove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years with the addition of the brown colorant. The glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® Brown Surgical Glove to provide the user with this additional feature: Slightly Curved Former with Independent/Displaced thumb.
The document describes the Biogel® OrthoPro® Brown Surgical Glove.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (requirements from ASTM D3577, 21 CFR 800.20, and ASTM D5712) | Reported Device Performance (Result) |
|---|---|---|
| Primary Skin Irritation | Not explicitly stated (implied non-irritating) | Gloves are non-irritating. |
| ISO Closed Patch Sensitization | Not explicitly stated (implied no sensitization potential) | Gloves do not display any potential for sensitization. |
| Dimensions | Requirements of ASTM D3577 | Gloves meet requirements of ASTM D3577. |
| Physical Properties | Requirements for rubber surgical gloves per ASTM D3577 | Gloves meet requirements for rubber surgical gloves per ASTM D3577. |
| Freedom from Holes | Requirements of 21 CFR 800.20 and ASTM D3577 | Gloves exceed the requirements of 21 CFR 800.20 and ASTM D3577. |
| Protein Extractables | Requirements of ASTM D5712 | Gloves meet requirements of ASTM D5712. |
| Powder Residual | Powder level requirements for "Powder-Free" designation per ASTM D3577 (using ASTM standard D6142, presumably |
§ 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).