510(k) · Cleared
ClearedPolyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrp Asia Pacific Sdn. Bhd. · KGO Surgeon'S Gloves
Cleared on Aug 31, 2023 as substantially equivalent to K222058 (Wrp Asia Pacific Sdn. Bhd., 2022) after a 183-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Aug 31, 2023
- Review
- 183 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032942 (2003). No later device cites it as a predicate yet.
- Root · 2 generations backK032942 Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves…Wrp Asia Pacific Sdn. Bhd. · 2003
- 1 generation backK222058 Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use…Wrp Asia Pacific Sdn. Bhd. · 2022
- This deviceK230578 Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested…Wrp Asia Pacific Sdn. Bhd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032942 | Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, Sterile | Wrp Asia Pacific Sdn. Bhd. | 2003 | — |
| −1 | K222058 | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with… | Wrp Asia Pacific Sdn. Bhd. | 2022 | — |
| 0 (this device) | K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use… | Wrp Asia Pacific Sdn. Bhd. | 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 |
|---|---|---|---|
| * | K222058 | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy…Summary page 5…Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance 510(k) Number K222058 Regulatory Class I Product Code KGO, LZC, OPJ 4.0 Description of The Device:… | 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 20 years and passes through 1 company; a new generation was cleared every 18.8 years on median.
- None of the 2 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. 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 sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following…
Read the full statement (196 words)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
Chemotherapy Drug (Concentration) Minimum Breakthrough Detection Time (Minutes)
*Carmustine (BCNU) (3.3 mg/ml) 67.6
Cisplatin (1.0 mg/ml) > 240
Cyclophosphamide (Cytoxan) (20.0 mg/ml) > 240
Dacarbazine (10.0 mg/ml) > 240
Doxorubicin Hydrochloride (2.0 mg/ml) > 240
Etoposide (20.0 mg/ml) > 240
Fluorouracil (50.0 mg/ml) > 240
Ifosfamide (50.0 mg/ml) > 240
Methotrexate (25.0 mg/ml) > 240
Mitomycin C (0.5 mg/ml) > 240
Mitoxantrone (2.0 mg/ml) > 240
Paclitaxel (6.0 mg/ml) > 240
*Thiotepa (10.0 mg/ml) 77.7
Vincristine Sulfate (1.0 mg/ml) > 240
*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 67.6 minutes and Thiotepa: 77.7. Do not use with Carmustine and Thiotepa.
Fentanyl Concentration Breakthrough Detection Time in Minutes
Fentanyl Citrate Injection 100mcg/2mL No breakthrough up to 240 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230578: Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230578
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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