510(k) · Cleared
ClearedLatex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs
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 May 26, 2022 after a 150-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- May 26, 2022
- Review
- 150 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK214074 Latex Powder Free Surgical Glove with Protein Labeling Claim of 50…Hartalega NGC Sdn. Bhd. · 2022
- Descendant · cites it directly · 0 of its ownK260558 Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy…Hartalega NGC Sdn. Bhd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl…Hartalega NGC Sdn. Bhd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K214074 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram… | Hartalega NGC Sdn. Bhd. | 2022 | — |
| +1 | K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and… | Hartalega NGC Sdn. Bhd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl… | 2026 | 0 |
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?
- Of its descendants, K260558 (Hartalega NGC Sdn. Bhd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of…
Read the full statement (187 words)
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) 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 (BCNU) (3.3 mg/ml) 12.5
Cisplatin (1 mg/ml) > 240
Cyclophosphamide (Cytoxan) (20.0 mg/ml) > 240
Dacarbazine (10 mg/ml) > 240
Doxorubicin HCI (2.0 mg/ml) > 240
Etoposide (20.0 mg/ml) > 240
Fluorouracil (50.0 mg/ml) > 240
Methotrexate (25 mg/ml) > 240
Mitomycin C (0.5 mg/ml) > 240
Paclitaxel (6.0 mg/ml) > 240
Thiotepa (10.0 mg/ml) 13.6
Vincristine Sulfate (1.0 mg/ml) > 240
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 12.5 minutes; Thiotepa 10.0 mg/ml 13.6 minutes. Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K214074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214074: Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with 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/K214074
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026