510(k) · Cleared
ClearedFlexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentienx Sdn Bhd · KGO Surgeon'S Gloves
Cleared on Aug 18, 2023 after a 324-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 18, 2023
- Review
- 324 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. 2023, 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 surgeon's glove is a device made of synthetic elastomer that is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and ASTM D6355-07, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves.…
Read the full statement (481 words)
A powder-free surgeon's glove is a device made of synthetic elastomer that is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and ASTM D6355-07, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves.
Chemotherapy Drugs Permeation
The following drugs have been tested with these gloves
No. Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes
1. Carmustine 3.3 mg/ml 7.7
2. Cisplatin 1.0 mg/ml >240
3. Cyclophosphamide 20.0 mg/ml >240
4. Dacarbazine 10.0 mg/ml >240
5. Doxorubicin HCI 2.0 mg/ml >240
6. Etoposide 20.0 mg/ml >240
7. Fluorouracil 50.0 mg/ml >240
8. Ifosfamide 50.0 mg/ml >240
9. Methotrexate 25.0 mg/ml >240
10. Mitomycin C 0.5 mg/ml >240
11. Paclitaxel (Taxol) 6.0 mg/ml >240
12. Thiotepa 10.0 mg/ml 11.4
13. Vincristine Sulfate 1.0 mg/ml >240
Warning: The permeation times for Carmustine and Thiotepa are extremely low with permeation times of 7.7 minutes and 11.4 minutes respectively. Do not use with Carmustine or Thiotepa.
A powder-free surgeon's glove is a device made of synthetic elastomer that is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and ASTM D6355-07, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves.
Chemotherapy Drugs Permeation
The following drugs have been tested with these gloves
No. Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes
1. Carmustine 3.3 mg/ml 11.9
2. Cisplatin 1.0 mg/ml >240
3. Cyclophosphamide 20.0 mg/ml >240
4. Dacarbazine 10.0 mg/ml >240
5. Doxorubicin HCI 2.0 mg/ml >240
6. Etoposide 20.0 mg/ml >240
7. Fluorouracil 50.0 mg/ml >240
8. Ifosfamide 50.0 mg/ml >240
9. Methotrexate 25.0 mg/ml >240
10. Mitomycin C 0.5 mg/ml >240
11. Paclitaxel (Taxol) 6.0 mg/ml >240
12. Thiotepa 10.0 mg/ml 12.3
13. Vincristine Sulfate 1.0 mg/ml >240
14. Bleomycin Sulfate 15.0 mg/ml >240
15. Busulfan 6.0 mg/ml >240
16. Carboplatin 10.0 mg/ml >240
17. Cytarabine HCI 100.0 mg/ml >240
18. Cytovene 10.0 mg/ml >240
19. Daunorubicin HCI 5.0 mg/ml >240
20. Docetaxel 10.0 mg/ml >240
21. Epirubicin HCI 2.0 mg/ml >240
22. Fludarabine 25.0 mg/ml >240
23. Gemcitabine (Gemzar) 38.0 mg/ml >240
24. Idarubicin HCI 1.0 mg/ml >240
25. Irinotecan 20.0 mg/ml >240
26. Mechlorethamine HCI 1.0 mg/ml >240
27. Melphalan 5.0 mg/ml >240
28. Mitoxantrone 2.0 mg/ml >240
29. Oxaliplatin 5.0 mg/ml >240
30. Rituximab 10.0 mg/ml >240
31. Trisenox 1.0 mg/ml >240
32. Vinorelbine 10.0 mg/ml >240
Warning : The permeation times for Carmustine and Thiotepa are extremely low with permeation times of 11.9 minutes and 12.3 minutes respectively. Do not use with Carmustine or Thiotepa.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K222993 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222993: Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222993
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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