(42 days)
The Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) 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 Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3577-01a"2 and FDA 21 CFR 800.20.
The provided text describes a 510(k) premarket notification for "Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less)". This document is for a medical device that is not an AI/ML powered device, therefore, many of the requested fields are not applicable.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS (Acceptance Criteria) | 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 |
| 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).