(23 days)
The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
The Powder Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577 - 00 and FDA 21 CFR 800.20.
The provided document describes the acceptance criteria and performance of the WRP Asia Pacific Sdn Bhd "Powder Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim)". Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3577 - 00 | Meets |
| Physical Properties | ASTM D 3577 - 00 | Meets |
| Freedom from pinholes | ASTM D 3577 - 00; FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 | Meets (2 mg/glove maximum) |
| Protein Level | ASTM D 5712 - 95 |
§ 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).