510(k) · Cleared
ClearedPowder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gx Corporation Sdn Bhd · KGO Surgeon'S Gloves
Cleared on Jul 9, 2021 after a 459-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 9, 2021
- Review
- 459 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?
A Powder Free White Sterilized Polyisoprene Surgical Gloves- Tested for Use with Chemotherapy Drugs is a disposable device intended for invasive surgery procedures that is to be worn on both the hands by operating room personnel to protect a surgical wound from contamination . These gloves were tested for use with Chemotherapy Drug as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug. List of tested…
Read the full statement (206 words)
A Powder Free White Sterilized Polyisoprene Surgical Gloves- Tested for Use with Chemotherapy Drugs is a disposable device intended for invasive surgery procedures that is to be worn on both the hands by operating room personnel to protect a surgical wound from contamination .
These gloves were tested for use with Chemotherapy Drug as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.
List of tested Chemotherapy Drugs are as follows:
Chemotherapy Drug Permeation and Concentration Average Breaktrough Detection Time (in Minutes)
1. Carmustine ( BCNU)3.3 mg/ml(3,300 ppm) 12.6 min
2. Cisplatin 1.0 mg/ml (1,000ppm) >240 min
3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) >240 min
4. Dacarbazine (DTIC)10.0 mg/ml(10,000ppm) >240 min
5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) >240 min
6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) >240 min
7. Fluorouracil 50.0 mg/ml (50,000ppm) >240 min
8. Ifosfamide 50.0 mg/ml (50,000ppm) >240 min
9. Methotrexate 25 mg/ml (25,000ppm) >240 min
10. Mitomycin C 0.5 mg/ml (500ppm) >240 min
11. Mitoxantrone 2.0 mg/ml (2,000ppm) >240 min
12.Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) >240 min
13. Thio-Tepa 10.0 mg/ml (10,000ppm) 12.0 min
14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) >240 min
Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200915: Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200915
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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