510(k) · Cleared
ClearedLatex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hartalega NGC Sdn. Bhd. · KGO Surgeon'S Gloves
Cleared on Jul 28, 2026 as substantially equivalent to K214074 (Hartalega NGC Sdn. Bhd., 2022) and 1 other predicate after a 159-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Jul 28, 2026
- Review
- 159 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022442 (2002). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK022442 Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and…Wrp Asia Pacific Sdn. Bhd. · 2002
- 1 generation backK032464 Aloetouch Powder Free Latex Surgical Gloves, Sterile, Coated with…Wrp Asia Pacific Sdn. Bhd. · 2003
- This deviceK260558 Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy…Hartalega NGC Sdn. Bhd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022442 | Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein… | Wrp Asia Pacific Sdn. Bhd. | 2002 | — |
| −1 | K032464 | Aloetouch Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera… | Wrp Asia Pacific Sdn. Bhd. | 2003 | — |
| 0 (this device) | K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and… | Hartalega NGC Sdn. Bhd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K214074 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per…Summary page 7…: 21 CFR 878.4460 Reason for 510(k) Submission : New device PREDICATE DEVICE INFORMATION 1. 510(k) Number : K214074 Manufacturer : Hartalega NGC Sdn. Bhd. Trade Name (Proprietary Name) : Latex P… | 2022 |
| * | K032464 | Aloetouch Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with…Summary page 7…Product Code : KGO, LZC Regulation Number : 21 CFR 878.4460 2. 510(k) Number : K032464 Manufacturer : WRP Asia Pacific Sdn. Bhd. Trade Name (Proprietary Name) : Powd… | 2003 |
| † | K143419 | Patient Examination Gloves | 2015 |
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.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 22.9 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is made of natural rubber intended to be worn by operating personnel to protect surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate. The glove was tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation…
Read the full statement (375 words)
Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is made of natural rubber intended to be worn by operating personnel to protect surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
The glove was tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes
Carmustine (3.3 mg/ml) 6.7
Cisplatin (1.0 mg/ml) > 240
Cyclophosphamide (20.0 mg/ml) > 240
Dacarbazine (10.0 mg/ml) > 240
Doxorubicin HCI (2.0 mg/ml) > 240
Etoposide (20.0 mg/ml) > 240
Fluorouracil (50.0 mg/ml) > 240
Methotrexate (25.0 mg/ml) > 240
Mytomycin C (0.5 mg/ml) > 240
Paclitaxel (6.0 mg/ml) > 240
Thiotepa (10.0 mg/ml) 11.5
Vincristine Sulfate (1.0 mg/ml) > 240
Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes
Fentanyl Citrate Injection (100mcg/2ml) >240
Caution: Testing showed a minimum breakthrough time of 6.7 minutes with Carmustine and 11.5 minutes with Thiotepa.
Warning: Do not use with Carmustine and Thiotepa
Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is made of natural rubber intended to be worn by operating personnel to protect surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
The glove was tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes
Carmustine (3.3 mg/ml) 7.7
Cisplatin (1.0 mg/ml) > 240
Cyclophosphamide (20.0 mg/ml) > 240
Dacarbazine (10.0 mg/ml) > 240
Doxorubicin HCI (2.0 mg/ml) > 240
Etoposide (20.0 mg/ml) > 240
Fluorouracil (50.0 mg/ml) > 240
Methotrexate (25.0 mg/ml) > 240
Mytomycin C (0.5 mg/ml) > 240
Paclitaxel (6.0 mg/ml) > 240
Thiotepa (10.0 mg/ml) 12.8
Vincristine Sulfate (1.0 mg/ml) > 240
Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes
Fentanyl Citrate Injection (100mcg/2ml) >240
Caution: Testing showed a minimum breakthrough time of 7.7 minutes with Carmustine and 12.8 minutes with Thiotepa.
Warning: Do not use with Carmustine and Thiotepa
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260558: Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260558
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026