(11 days)
The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with 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 Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) is equivalent to the exiting model, i.e. Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) which had submitted and cleared under 510(k) number K022442.
The difference in this submission is:
- No colour additive is added. a)
The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3577 - 01a52 and FDA 21 CFR 800.20.
The provided document is a 510(k) summary for a medical device, specifically Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard (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 (Waterleak test on pinhole AQL) |
| Powder Residual | 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).