510(k) · Cleared
ClearedSensiCare PI Ortho LT 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
Medline Industries, Inc. · KGO Surgeon'S Gloves
Cleared on Aug 2, 2021 after a 242-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 2, 2021
- Review
- 242 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. 2021, 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 disposable device made of synthetic rubber latex intended to be worn by surgeon's and or 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 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The following chemicals have been tested with the glove. Chemotherapy Drug…
Read the full statement (233 words)
The surgeon's glove is a disposable device made of synthetic rubber latex intended to be worn by surgeon's and or 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 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with the glove.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
Bleomycin 15 mg/ml >240 minutes
Busulfan 6 mg/ml >240 minutes
Carboplatin 10.0 mg/ml >240 minutes
Carumstine (BCNU) 3.3 mg/ml 25.8 minutes (25.8, 34.1, 35.4)
Cisplatin 1.0 mg/ml >240 minutes
Cyclophosphamide (Cytoxan) 20 mg/ml >240 minutes
Cytarabine 100 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
lfosfamide 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 0.5mg/ml >240 minutes
Mitoxantrone 2.0 mg/ml >40 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 34.6 minutes (37.5, 37.8, 34.6)
Vincristine Sulfate 1.0 mg/ml >240 minutes
Warning: Do not use with Carmustine
Caution: Testing showed a minimum breakthrough time of 34.6 minutes with Thiotepa
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K203538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203538: SensiCare PI Ortho LT 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/K203538
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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