510(k) · Cleared
ClearedSterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harps Europe Manufacturing GmbH · KGO Surgeon'S Gloves
Cleared on Aug 19, 2025 as substantially equivalent to K160781 (Semperit Investments Asia Pte, Ltd., 2017) after a 197-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Aug 19, 2025
- Review
- 197 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981096 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK981096 Sempermed Surgeons' Gloves - SupremeSemperit Technische Produkte Gesellshaft · 1998
- 2 generations backK013560 Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9Semperit Technische Produkte Gesellshaft · 2002
- 1 generation backK160781 Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons…Semperit Investments Asia Pte, Ltd. · 2017
- This deviceK250313 Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color…Harps Europe Manufacturing GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981096 | Sempermed Surgeons' Gloves - Supreme | Semperit Technische Produkte Gesellshaft | 1998 | — |
| −2 | K013560 | Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9 | Semperit Technische Produkte Gesellshaft | 2002 | — |
| −1 | K160781 | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves | Semperit Investments Asia Pte, Ltd. | 2017 | — |
| 0 (this device) | K250313 | Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For… | Harps Europe Manufacturing GmbH | 2025 | — |
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 |
|---|---|---|---|
| * | K160781 | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons GlovesSummary page 6…I Product Code: KGO, LZC Classification Panel: General and Plastic Surgery Legally Marketed Predicate Device Primary Predicate: K160781 Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeon… | 2017 |
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 27 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination. The tested drugs are: Compound Minimum Breakthrough Time (minutes) Carmustine (BCNU) (3.3 mg/ml) 15.8 Cyclophosphamide (20 mg/ml) >240 Doxorubicin (2 mg/ml) >240 Etoposide (Toposar) (20 mg/ml) >240…
Read the full statement (248 words)
The Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.
The tested drugs are:
Compound Minimum Breakthrough Time (minutes)
Carmustine (BCNU) (3.3 mg/ml) 15.8
Cyclophosphamide (20 mg/ml) >240
Doxorubicin (2 mg/ml) >240
Etoposide (Toposar) (20 mg/ml) >240
Fluorouracil (50 mg/ml) >240
Paclitaxel (6 mg/ml) >240
Thiotepa (THT) (10 mg/ml) 24.6
Bleomycin sulfate (15 mg/ml) >240
Carboplatin (10 mg/ml) >240
Cisplatin (1 mg/ml) >240
Cytarabine (100 mg/ml) >240
Dacarbazine (10 mg/ml) >240
Daunorubicin HCl (5 mg/ml) >240
Docetaxel (10 mg/ml) >240
Gemcitabine HCl (38 mg/ml) >240
Idarubicin HCl (1 mg/ml) >240
Ifosfamide (50 mg/ml) >240
Irinotecan HCl (20 mg/ml) >240
Mechlorethamine HCl (1 mg/ml) >240
Melphalan HCl (5 mg/ml) >240
Methotrexate (25 mg/ml) >240
Mitomycin C (0.5 mg/ml) >240
Mitoxantrone (2 mg/ml) >240
Vincristine Sulfate (1 mg/ml) >240
Busulfan (6 mg/ml) >240
Chloroquine (50 mg/ml) >240
Cyclosporin A (100 mg/ml) >240
Epirubicin HCl (2 mg/ml) >240
Fludarabine Phosphate (25 mg/ml) >240
Oxaliplatin (2 mg/ml) >240
Retrovir (10 mg/ml) >240
Rituximab (10 mg/ml) >240
Topotecan HCl (1 mg/ml) >240
Trisenox (Arsenic Trioxide) (1 mg/ml) >240
Velcade (Bortezomib) (1 mg/ml) >240
Simulated Gastric Acid Fluid was also tested with a minimum breakthrough greater than 240 minutes.
WARNING:
Please note the following drugs have extremely low permeation times:
Carmustine: 15.8 minutes and Thiotepa: 24.6 minutes. Do not use with Carmustine and Thiotepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250313: Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250313
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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