(72 days)
The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated 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 Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera meets all the requirements of ASTM standard D 3577 - 01a22 and FDA 21 CFR 800.20.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera (Trade Names: Aloetouch, Multiple or Customer's Trade Name)
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA | DEVICE PERFORMANCE |
|---|---|---|---|
| Dimensions | ASTM D 3577 - 01aE2 | Meets ASTM D 3577 - 01aE2 | Meets (reported as "Meets") |
| Physical Properties | ASTM D 3577 - 01aE2 | Meets ASTM D 3577 - 01aE2 | Meets (reported as "Meets") |
| Freedom from pinholes | ASTM D 3577 - 01aE2 | Meets ASTM D 3577 - 01aE2 and FDA 21 CFR 800.20 for water leak test on pinhole AQL | Meets (reported as "Meets") |
| FDA 21 CFR 800.20 | |||
| Powder-Free | ASTM D 6124 - 01 |
§ 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).