510(k) · Cleared
ClearedSensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · KGO Surgeon'S Gloves
Cleared on Nov 27, 2015 as substantially equivalent to K111139 (Ansell Healthcare Products, Inc., 2011) after a 298-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Nov 27, 2015
- Review
- 298 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013302 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK013302 Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested…Allegiance Healthcare Corp. · 2001
- 1 generation backK111139 Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical…Ansell Healthcare Products, Inc. · 2011 · Recalled
- This deviceK150238 SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical…Medline Industries, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013302 | Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use… | Allegiance Healthcare Corp. | 2001 | — |
| −1 | K111139 | Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves… | Ansell Healthcare Products, Inc. | 2011 | 3 |
| 0 (this device) | K150238 | SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With… | Medline Industries, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K111139 | Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for USummary page 4…e: Surgeon’s Glove Device Class : I Classification Name: Surgeon’s Glove (21 CFR 878.4460) Product Code: KGO Classification Panel: General Hospital Predicate Device K111139 - Derma Prene IsoTouch Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs Device Des… | 2011 |
| † | K102177 | Sensicare Powder-Free Polymer Coated Polysoprene Surgical Gloves, Sterile | 2011 |
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 14 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K111139.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The surgeon’s glove is a device made of synthetic rubber latex intended to be worn by surgeons and /or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs. Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes The following chemicals have been tested with these gloves. Carmustine Avg. 15.7 (15.7,16.3,17.0) Cisplatin 240 min. Cyclophosphamide (Cytoxan) 240 min. Dacarbazine…
Read the full statement (111 words)
The surgeon’s glove is a device made of synthetic rubber latex intended to be worn by surgeons and /or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
The following chemicals have been tested with these gloves.
Carmustine Avg. 15.7 (15.7,16.3,17.0)
Cisplatin 240 min.
Cyclophosphamide (Cytoxan) 240 min.
Dacarbazine (DTIC) 240 min.
Doxorubicin Hydrochloride 240 min.
Etoposide (Toposar) 240 min.
Fluorouracil 240 min.
Ifosfamide 240 min.
Methotrexate 240 min.
Mitomycin C 240 min.
Paclitaxel (Taxol) 240 min.
Thiotepa Avg. 15.3 min. (15.3,15.3,15.3)
Vincristine Sulfate 240 min.
WARNING: Do not use with Carmustine and Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150238: SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150238
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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