# K201592: Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Sep 26, 2021 after 471 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Cardinal Health™ Protexis™ PI Blue with Neu-Thera™ Surgical Gloves are powder-free surgeon's gloves that are disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, “Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.” Chemotherapy Drug Permeation Resistance (minimum breakthrough detection time in minutes, 0.01 μg/cm2/min): Carmustine (3.3 mg/mL) 18.5 Cisplatin (1 mg/mL) >240 Cyclophosphamide (20 mg/mL) >240 Doxorubicin Hydrochloride (2 mg/mL) >240 Etoposide (20 mg/mL) >240 5-Fluorouracil (50 mg/mL) >240 Methotrexate (25 mg/mL) >240 Mitomycin C (0.5 mg/mL) >240 Paclitaxel (6 mg/mL) >240 Thiotepa (10 mg/mL) 24.4 Vincristine Sulfate (1 mg/mL) >240 Please note that the gloves showed extremely low permeation times of 18.5 and 24.4 minutes respectively with Carmustine (BCNU) (3.3 mg/mL) and Thiotepa (10 mg/mL). When chemotherapy drugs are present, gloves selection should be based on the specific type(s) of chemicals used. Users are recommended to review drug labeling or material safety data sheets for the chemicals being used to determine an adequate level of protection.

Source page: https://510kreport.com/device/K201592
Methodology: https://510kreport.com/methodology