510(k) · Cleared
ClearedSensiCare PI Surgical Gloves
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 31, 2016 as substantially equivalent to K110272 (Cardinal Health, Inc., 2011) after a 218-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Mar 31, 2016
- Review
- 218 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011721 (2001). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK011721 Esteem Sterile Polyisoprene Surgical GlovesAllegiance Healthcare Corp. · 2001
- 2 generations backK093300 Esteem SMT Polyisoprene Powder-Free Surgical Sterile GlovesCardinal Health, Inc. · 2009
- 1 generation backK110272 Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with…Cardinal Health, Inc. · 2011 · Recalled
- This deviceK152428 SensiCare PI Surgical GlovesMedline Industries, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK171898 Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use…Better Care Plastic Technology Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK161823 Powder Free Nitrile Surgical Glove, Sterile, Tested for use with…Wrp Asia Pacific Sdn. Bhd. · 2017
Most influential descendants
Showing 2 of 2 · See all- K171898Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy DrugsBetter Care Plastic Technology Co., Ltd. · 2017 · cites it directly0descendants
- K161823Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy DrugsWrp Asia Pacific Sdn. Bhd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011721 | Esteem Sterile Polyisoprene Surgical Gloves | Allegiance Healthcare Corp. | 2001 | — |
| −2 | K093300 | Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves | Cardinal Health, Inc. | 2009 | — |
| −1 | K110272 | Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with… | Cardinal Health, Inc. | 2011 | 1 |
| 0 (this device) | K152428 | SensiCare PI Surgical Gloves | Medline Industries, Inc. | 2016 | — |
| +1 | K171898 | Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With… | Better Care Plastic Technology Co., Ltd. | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 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? (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 |
|---|---|---|---|
| * | K110272 | Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy DrugSummary page 5…ation #: 21 CFR 878.4460 Classification Panel: General Hospital Predicate Device Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs K110272 Device Description The SensiCare PI Surgical Gloves are disposable powder-free surgical gloves that are intended to be worn by s… | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K171898 (Better Care Plastic Technology Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K110272.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 SensiCare PI surgeon's glove is a disposable device made of synthetic rubber intended to be worn by 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 these gloves. Chemotherapy Drug Permeation…
Read the full statement (230 words)
The SensiCare PI surgeon's glove is a disposable device made of synthetic rubber intended to be worn by 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 these gloves.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 10.1 min. (10.1, 10.1, 10.1)
Cisplatin 1.0 mg/ml (1,000 ppm) 240 min.
Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) 240 min.
Cytarabine 100 mg/ml (100,000 ppm) 240 min.
Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) 240 min.
Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) 240 min.
Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) 240 min.
Fluorouracil 50.0 mg/ml (50,000 ppm) 240 min.
Ifosfamide 50.0 mg/ml (50,000 ppm) 240 min.
Methotrexate 25 mg/ml (25,000 ppm) 240 min.
Mitomycin C 0.5 mg/ml (500 ppm) 240 min.
Mitoxantrone 2.0 mg/ml (2,000 ppm) 240 min.
Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) 240 min.
Thiotepa 10.0 mg/ml (10,000 ppm) 11.6 min. (20.2, 21.5, 11.6)
Vincristine Sulfate 1.0 mg/ml (1,000 ppm) 240 min.
Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (3.3 mg/ml) has a minimum breakthrough time of 10.1 minutes; Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 11.6 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152428: SensiCare PI Surgical Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152428
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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