(54 days)
The Powder Free Green Neoprene Surgical Glove, Sterile with Aloe Vera is made of synthetic rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
The Powder Free Green Neoprene Surgical Glove, Sterile with Aloe Vera meets all the requirements of ASTM standard D 3577 - 01a22 and FDA 21 CFR 800.20.
This document describes the process for obtaining 510(k) clearance for the WRP Asia Pacific Sdn Bhd "Powder Free Green Neoprene Surgical Glove, Sterile with Aloe Vera". The clearance is based on the device meeting established performance standards and being substantially equivalent to legally marketed predicate devices.
Here's the breakdown of the acceptance criteria and the "study" that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3577 - 01aE2 | Meets |
| Physical Properties | ASTM D 3577 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01aE2, FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 | Meets ( |
§ 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).