510(k) · Cleared
ClearedCardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health200, LLC · KGO Surgeon'S Gloves
Cleared on Sep 26, 2021 after a 471-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 26, 2021
- Review
- 471 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGO device
- #1 K192328 JR.MEDIK Latex Surgeon’s Gloves Powder Freescore 15.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · KGO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGO
185in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGO
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGO
21in 2025
MAUDE reports naming product code KGO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 113 | 0 | 13 |
| 2008 | 2 | — | 0 | 8 |
| 2009 | 3 | 48 | 15 | 14 |
| 2010 | 6 | 87 | 1 | 16 |
| 2011 | 11 | 90 | 0 | 14 |
| 2012 | 7 | 133 | 0 | 14 |
| 2013 | 6 | 184 | 0 | 41 |
| 2014 | 7 | 257 | 0 | 28 |
| 2015 | 12 | 225 | 0 | 11 |
| 2016 | 9 | 218 | 2 | 15 |
| 2017 | 12 | 111 | 1 | 20 |
| 2018 | 7 | 194 | 8 | 15 |
| 2019 | 11 | 204 | 0 | 51 |
| 2020 | 15 | 117 | 0 | 15 |
| 2021 | 14 | 199 | 0 | 14 |
| 2022 | 6 | 127 | 2 | 10 |
| 2023 | 14 | 185 | 2 | 28 |
| 2024 | 2 | — | 0 | 18 |
| 2025 | 1 | — | 0 | 21 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (193 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K201592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201592: Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201592
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026