(114 days)
The surgical 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 Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim is equivalent to the existing model, i.e. Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) Contains 50 Micrograms or Less of Total Water Extractable Protein per gram which had submitted and cleared under 510(k) number K021784. The difference in this submission is: With Aloe Vera coated on surgical gloves.
The provided document describes a medical device, "Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim," and its equivalence to a predicate device. The information presented is for a 510(k) premarket notification and focuses on demonstrating that the modified device meets established standards.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standards | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 3577 - 06 | Meets ASTM D 3577 - 06 | Meets |
| Physical Properties | ASTM D 3577 - 06 | Meets ASTM D 3577 - 06 | Meets |
| Freedom from pinholes | ASTM D 3577 - 06 & FDA 21 CFR 800.20 | Meets ASTM D 3577 - 06 & FDA 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 6124 - 06 |
§ 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).