510(k) · Cleared
ClearedPowder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
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 Jan 23, 2017 as substantially equivalent to K153316 (Cardinal Health, Inc., 2016) and 1 other predicate after a 206-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jan 23, 2017
- Review
- 206 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K011721 (2001). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK011721 Esteem Sterile Polyisoprene Surgical GlovesAllegiance Healthcare Corp. · 2001
- 3 generations backK093300 Esteem SMT Polyisoprene Powder-Free Surgical Sterile GlovesCardinal Health, Inc. · 2009
- 2 generations backK110272 Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with…Cardinal Health, Inc. · 2011 · Recalled
- 1 generation backK152428 SensiCare PI Surgical GlovesMedline Industries, Inc. · 2016
- This deviceK161823 Powder Free Nitrile Surgical Glove, Sterile, Tested for use with…Wrp Asia Pacific Sdn. Bhd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011721 | Esteem Sterile Polyisoprene Surgical Gloves | Allegiance Healthcare Corp. | 2001 | — |
| −3 | K093300 | Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves | Cardinal Health, Inc. | 2009 | — |
| −2 | K110272 | Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with… | Cardinal Health, Inc. | 2011 | 1 |
| −1 | K152428 | SensiCare PI Surgical Gloves | Medline Industries, Inc. | 2016 | — |
| 0 (this device) | K161823 | Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy… | Wrp Asia Pacific Sdn. Bhd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and…Summary page 5…or Use with Chemotherapy Drugs (Yellow) 510(k) Number K153316 K152428 Regulatory Class I I Product Code KGO, LZC KGO, LZC 4.0… | 2016 |
| * | K152428 | SensiCare PI Surgical GlovesSummary page 5…with Chemotherapy Drugs (Yellow) 510(k) Number K153316 K152428 Regulatory Class I I Product Code KGO, LZC KGO, LZC 4.0 Description of The… | 2016 |
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 16 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 8 ancestors have 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. 2017, 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 surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 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…
Read the full statement (146 words)
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 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 Breakthrough Detection Time in Minutes
*Carmustine (BCNU) 3.3mg/ml 30.4
Cisplatin 1.0mg/ml > 240
Cyclophosphamide (Cytoxan) 20.0mg/m! >240
Dacarbazine 10.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/mi > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Ifosfamide 50.0mg/ml > 240
Mitoxantrone 2.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
*Thiotepa - 10.0mg/mi 59.0
Vingristine Sulfate 1.0mg/ml > 240
CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for 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/K161823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161823: Powder Free Nitrile Surgical Glove, Sterile, 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/K161823
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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