510(k) · Cleared
ClearedNUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terang Nusa Snd Bhd · KGO Surgeon'S Gloves
Cleared on Aug 4, 2015 after a 113-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 4, 2015
- Review
- 113 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. 2015, 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 Surgeons glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves are tested for use with Chemotherapy Drugs. Testing based on ASTM D6978-05 DRUG — Minimum Breakthrough Detection Time (Specimen 1/2/3), Minutes Carmustine (BCNU), 3.3 mg/ml (3,300ppm) — 30.6 (30.6, 30.6, 30.8) Cisplatin, 1.0 mg/ml (1,000ppm) — Up to 240 Cyclophosphamide (Cytoxan), 20 mg/ml…
Read the full statement (152 words)
This Surgeons glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves are tested for use with Chemotherapy Drugs.
Testing based on ASTM D6978-05
DRUG — Minimum Breakthrough Detection Time (Specimen 1/2/3), Minutes
Carmustine (BCNU), 3.3 mg/ml (3,300ppm) — 30.6 (30.6, 30.6, 30.8)
Cisplatin, 1.0 mg/ml (1,000ppm) — Up to 240
Cyclophosphamide (Cytoxan), 20 mg/ml (20,000ppm) — Up to 240
Dacarbazine (DTIC), 10.0 mg/ml (10,000ppm) — Up to 240
Doxorubicin Hydrochloride, 2.0 mg/ml (2,000ppm) — Up to 240
Etoposide (Toposar), 20.0 mg/ml (20,000ppm) — Up to 240
Paclitaxel (Taxol), 6.0 mg/ml (6,000ppm) — Up to 240
Fluorouracil, 50.0 mg/ml (50,000ppm) — Up to 240
Thiotepa, 10.0 mg/ml (10,000ppm) — 31.2 (31.2, 60.8, 61.3)
Vincristine Sulfate, 1.0 mg/ml (1,000ppm) — Up to 240
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 30.6
Thiotepa 31.2
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K150973 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150973: NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150973
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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