(20 days)
The Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) are made of natural 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 natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
The Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577 - 0151 and FDA 21 CFR 800.20.
The document describes the acceptance criteria and performance of Powder Free Polymer Coated Latex Surgical Gloves. It is a 510(k) summary for a medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA (from Standards) | REPORTED DEVICE PERFORMANCE |
|---|---|---|---|
| Dimensions | ASTM D 3577 - 01E1 | As per ASTM D 3577 - 01E1 | Meets |
| Physical Properties | ASTM D 3577 - 01E1 | As per ASTM D 3577 - 01E1 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01E1 & FDA 21 CFR 800.20 | As per ASTM D 3577 - 01E1 & FDA 21 CFR 800.20 | Meets |
| 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).