(90 days)
This powder-free surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is a disposable device intended for over the counter use and is provided powder-free sterile. It is made with natural rubber latex. The glove is coated with nitrile coating. The glove is manufactured using exact same material used in the currently cleared device, Protegrity Blue glove (K053272). The glove is coated with emollient coating (containing Glycerol. Gluconolactone, D-Sorbitol and Provitamin-B). The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down.
The provided text describes the acceptance criteria and performance of Cardinal Health Protexis™ Latex Powder-Free Blue Surgical Gloves with Neu-Thera® Coating. It is a 510(k) submission, meaning the device is seeking substantial equivalence to a legally marketed predicate device, not necessarily proving revolutionary new efficacy.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility: | ||
| Primary Skin Irritation | ISO 10993-10 (Pass) | Gloves are non-irritating. (Meets requirements) |
| Guinea Pig Maximization | ISO 10993-10 (Pass) | Gloves do not display any potential for sensitization. (Meets requirements) |
| Physical Characteristics: | ||
| Dimensions | ASTM D3577 requirements | Meet requirements. (Meets requirements for rubber surgical gloves) |
| Physical Properties | ASTM D3577 requirements | Meet requirements for rubber surgical gloves. (Meets requirements) |
| Freedom from Holes | AQL meets 21CFR 800.20 & ASTM D3577 requirements | Tested in accordance with ASTM D5151 with acceptable results. (Meets requirements) |
| Powder Residual | ≤2.0 mg/glove for Powder-Free designation per ASTM D3577 | **Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577. Results generated values |
§ 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).