510(k) · Cleared
ClearedPolychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pt. Medisafe Technologies · KGO Surgeon'S Gloves
Cleared on Apr 20, 2018 after a 192-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 20, 2018
- Review
- 192 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. 2018, 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?
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below. Test Chemotherapy Drug and Concentration Breakthrough Detection Time (Minutes) Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 37.5 (47.8, 38.3, 37.5) Cisplatin 1.0 mg/ml (1,000ppm) >240…
Read the full statement (188 words)
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
Test Chemotherapy Drug and Concentration Breakthrough Detection Time (Minutes)
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 37.5 (47.8, 38.3, 37.5)
Cisplatin 1.0 mg/ml (1,000ppm) >240 min
Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) >240 min
Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) >240 min
Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) >240 min
Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) >240 min
Fluorouracil 50.0 mg/ml (50,000 ppm) >240 min
Ifosfamide 50.0 mg/ml (50,000 ppm) >240 min
Methotrexate 25 mg/ml (25, 000 ppm) >240 min
Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) >240 min
Melphalan 5 mg/ml (5,000 ppm) >240 min
Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) >240 min
Thiotepa 10.0 mg/ml (10,000 ppm) 58.3 (69.8, 68.6, 58.3)
Vincristine Sulfate 1.0 mg/ml (1,000 ppm) >240 min
Caution: Testing showed an average breakthrough time for Carmustine (3.3 mg/ml): 37.5 minutes and average breakthrough time of ThioTEPA (10.0 mg/ml): 58.3 minutes
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K173258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173258: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173258
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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