510(k) · Cleared
Recalled · Class II · 2022Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Inc. · KGO Surgeon'S Gloves
Cleared on Jun 8, 2011 as substantially equivalent to K093300 (Cardinal Health, Inc., 2009) and 1 other predicate after a 128-day review. Its family tree reaches back 2 generations to 2001. 6 later devices descend from it. It has been recalled once.
- Decided
- Jun 8, 2011
- Review
- 128 days
- Class
- Class I
- Product code
- KGO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011721 (2001). 3 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK011721 Esteem Sterile Polyisoprene Surgical GlovesAllegiance Healthcare Corp. · 2001
- 1 generation backK093300 Esteem SMT Polyisoprene Powder-Free Surgical Sterile GlovesCardinal Health, Inc. · 2009
- This deviceK110272 Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with…Cardinal Health, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK152428 SensiCare PI Surgical GlovesMedline Industries, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK140477 Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove…Molnlycke Health Care Us, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK193573 Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel…Molnlycke Health Care Us, LLC · 2020
- Descendant · 2 generations on · 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 ownK170198 Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical…Cardinal Health, Inc. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K152428SensiCare PI Surgical GlovesMedline Industries, Inc. · 2016 · cites it directly2descendants
- K140477Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove SeriesMolnlycke Health Care Us, LLC · 2015 · cites it directly1descendant
- K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator…Molnlycke Health Care Us, LLC · 2020 · 2 generations on0descendants
- K171898Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy DrugsBetter Care Plastic Technology Co., Ltd. · 2017 · 2 generations on0descendants
- K170198Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use…Cardinal Health, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011721 | Esteem Sterile Polyisoprene Surgical Gloves | Allegiance Healthcare Corp. | 2001 | — |
| −1 | K093300 | Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves | Cardinal Health, Inc. | 2009 | — |
| 0 (this device) | K110272 | Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with… | Cardinal Health, Inc. | 2011 | — |
| +1 | K152428 | SensiCare PI Surgical Gloves | Medline Industries, Inc. | 2016 | — |
| +1 | K140477 | Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove Series | Molnlycke Health Care Us, LLC | 2015 | — |
| +2 | K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI… | Molnlycke Health Care Us, LLC | 2020 | — |
| +2 | K171898 | Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With… | Better Care Plastic Technology Co., Ltd. | 2017 | — |
| +1 | K170198 | Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested… | Cardinal Health, Inc. | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K093300 | Esteem SMT Polyisoprene Powder-Free Surgical Sterile GlovesSummary page 1…21 CFR 878.4460 Product Codle(s): KGO Legally marketed 1. Esteem* SMT Sterile Polyisoprene Powder-Free Surgical Gloves (510(k) device(s) to which K093300, product code KGO) equivalence is claimed: 2. Duraprene Sterile Neoprene Powder-Free Surgical Gloves (510(k) K013302,… | 2009 |
| * | K013302 | Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with…Summary page 1…Free Surgical Gloves (510(k) device(s) to which K093300, product code KGO) equivalence is claimed: 2. Duraprene Sterile Neoprene Powder-Free Surgical Gloves (510(k) K013302, product code KGO) Reason for 510(k) Submission: Addition of new indications for use: Teste… | 2001 |
What descends from it? (6)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2022 | Class II | Z-0902-2022 | Under Investigation by firm | Product was distributed without being sterilized. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K152428 (Medline Industries, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K093300.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 powder-free 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. Chemotherapy drug and concentration — Minimum breakthrough detection time in minutes, 0.01…
Read the full statement (239 words)
This powder-free 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.
Chemotherapy drug and concentration — Minimum breakthrough detection time in minutes, 0.01 μg/cm²/minute:
Blenoxane (15 mg/ml) — >240
Busulfan (6 mg/ml) — >240
Carmustine (BCNU) (3.3 mg/ml) — 0.37
Cisplatin (1.0 mg/ml) — >240
Cytarabine (100 mg/ml) — >240
Cyclophosphamide (20 mg/ml) — >240
Dacarbazine (10 mg/ml) — >240
Doxorubicin HCl (2.0 mg/ml) — >240
Ellence (25 mg/ml) — >240
Etoposide (Toposar) (20 mg/ml) — >240
Fludarabine (25 mg/ml) — >240
Fluorouracil (50 mg/ml) — >240
Idarubicin (1 mg/ml) — >240
Ifosfamide (50 mg/ml) — >240
Mechlorethamine HCl (1 mg/ml) — >240
Melphalan (5 mg/ml) — >240
Methotrexate (25 mg/ml) — >240
Mitoxantrone (2 mg/ml) — >240
Mitomycin C (0.5 mg/ml) — >240
Paclitaxel (Taxol) (6.0 mg/ml) — >240
Paraplatin (10 mg/ml) — >240
Rituximab (10 mg/ml) — >240
Thiotepa (10 mg/ml) — 0.44
Trisenox (0.1 mg/ml) — >240
Vincristine sulfate (1 mg/ml) — >240
Please note that the following drugs have extremely low permeation time of less than 30 minutes:
Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.37 minute.
Thiotepa (10 mg/ml) has a minimum breakthrough time of 0.44 minute.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110272: Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110272
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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