510(k) · Cleared
ClearedSensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V
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 Mar 6, 2020 after a 233-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 6, 2020
- Review
- 233 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
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.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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 Bleomycin 15 mg/ml >240 minutes Busulfan 6 mg/ml >240 minutes Carboplatin 10.0 mg/ml >240 minutes…
Read the full statement (396 words)
This 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
Bleomycin 15 mg/ml >240 minutes
Busulfan 6 mg/ml >240 minutes
Carboplatin 10.0 mg/ml >240 minutes
Carmustine (BCNU) 3.3 mg/ml 22.5 (23.4, 23.8, 22.5) minutes
Cisplatin 1.0 mg/ml >240 minutes
Cyclophosphamide (Cytoxan) 20 mg/ml >240 minutes
Dacarbazine (DTIC) 10.0 mg/ml >240 minutes
Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes
Epirubicin (Ellence) 2 mg/ml >240 minutes
Etoposide (Toposar) 20.0 mg/ml >240 minutes
Fludarabine 25.0 mg/ml >240 minutes
Fluorouracil 50.0 mg/ml >240 minutes
Idarubicin 1.0 mg/ml >240 minutes
Ifosfamide 50.0 mg/ml >240 minutes
Mechlorethamine HCI 1.0 mg/ml >240 minutes
Melphalan 5 mg/ml >240 minutes
Methotrexate 25 mg/ml >240 minutes
Mitomycin C 0.5 mg/ml >240 minutes
Mitoxantrone 2.0 mg/ml >240 minutes
Paclitaxel (Taxol) 6.0 mg/ml >240 minutes
Paraplatin 10 mg/ml >240 minutes
Rituximab 10 mg/ml >240 minutes
Thiotepa 10.0 mg/ml 24.4 (25.3, 24.4, 25.6) minutes
Vincristine Sulfate 1.0 mg/ml >240 minutes
Warning: Do not use with Carmustine and Thiotepa
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
Bleomycin 15 mg/ml >240 minutes
Busulfan 6 mg/ml >240 minutes
Carboplatin 10.0 mg/ml >240 minutes
Carmustine (BCNU) 3.3 mg/ml 13.7 (14.4, 14.4, 13.7) minutes
Cisplatin 1.0 mg/ml >240 minutes
Cyclophosphamide (Cytoxan) 20 mg/ml >240 minutes
Dacarbazine (DTIC) 10.0 mg/ml >240 minutes
Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes
Epirubicin (Ellence) 2 mg/ml >240 minutes
Etoposide (Toposar) 20.0 mg/ml >240 minutes
Fludarabine 25.0 mg/ml >240 minutes
Fluorouracil 50.0 mg/ml >240 minutes
Idarubicin 1.0 mg/ml >240 minutes
Ifosfamide 50.0 mg/ml >240 minutes
Mechlorethamine HCI 1.0 mg/ml >240 minutes
Melphalan 5 mg/ml >240 minutes
Methotrexate 25 mg/ml >240 minutes
Mitomycin C 0.5 mg/ml >240 minutes
Mitoxantrone 2.0 mg/ml >240 minutes
Paclitaxel (Taxol) 6.0 mg/ml >240 minutes
Paraplatin 10 mg/ml >240 minutes
Rituximab 10 mg/ml >240 minutes
Thiotepa 10.0 mg/ml 13.8 (13.8, 16.4, 14.8) minutes
Vincristine Sulfate 1.0 mg/ml >240 minutes
Warning: Do not use with Carmustine and Thiotepa
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K191915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191915: SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191915
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026