510(k) · Cleared
ClearedSterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grand Work Plastic Products Co., Ltd. · KGO Surgeon'S Gloves
Cleared on May 13, 2023 as substantially equivalent to K221718 (Hartalega NGC Sdn. Bhd., 2022) after a 107-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- May 13, 2023
- Review
- 107 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K013302 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK013302 Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested…Allegiance Healthcare Corp. · 2001
- 3 generations backK111139 Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical…Ansell Healthcare Products, Inc. · 2011 · Recalled
- 2 generations backK190018 Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for…Ansell Healthcare Products, LLC · 2019
- 1 generation backK221718 Polyisoprene Powder Free Surgical Glove Tested for Use with…Hartalega NGC Sdn. Bhd. · 2022
- This deviceK230217 Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with…Grand Work Plastic Products Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K013302 | Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use… | Allegiance Healthcare Corp. | 2001 | — |
| −3 | K111139 | Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves… | Ansell Healthcare Products, Inc. | 2011 | 3 |
| −2 | K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with… | Ansell Healthcare Products, LLC | 2019 | — |
| −1 | K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs… | Hartalega NGC Sdn. Bhd. | 2022 | — |
| 0 (this device) | K230217 | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with… | Grand Work Plastic Products Co., Ltd. | 2023 | — |
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? (1)
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 |
|---|---|---|---|
| * | K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)Summary page 4…C Device Class: Class I 3. Predicate Device Information: Hartalega NGC SDN BHD Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) (K221718) 4. Device Description: Sterile Polyisoprene Powder Free Surgical Glove, tested for Use with Chemotherapy Drugs is a disposable… | 2022 |
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 22 years and passes through 5 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
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?
This glove 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 D6978-05(Reapproved 2019). Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes Carmustine (3.3mg/ml) 25.4 Cisplatin (1mg/ml) >240 Cyclophosphamide (20mg/ml) >240 Doxorubicin HCL (2 mg/ml) >240 Etoposide (20mg/ml) >240 Fluorouracil…
Read the full statement (107 words)
This glove 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 D6978-05(Reapproved 2019).
Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes
Carmustine (3.3mg/ml) 25.4
Cisplatin (1mg/ml) >240
Cyclophosphamide (20mg/ml) >240
Doxorubicin HCL (2 mg/ml) >240
Etoposide (20mg/ml) >240
Fluorouracil (50mg/ml) >240
Methotrexate (25mg/ml) >240
Mitomycin C (0.5 mg/ml) >240
Paclitaxel (6mg/ml) >240
Thiotepa (10mg/ml) 23.3
Vincristine Sulfate (1mg/ml) >240
Please note that the following drugs have low permeation times:
Carmustine (BCNU): 25.4 minutes, Thiotepa: 23.3 minutes
Warning: Do not use with Carmustine and Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230217: Sterile Polyisoprene Powder Free Surgical Glove, 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/K230217
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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