510(k) · Cleared
ClearedPowder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smart Glove Corporation Sdn. Bhd. · KGO Surgeon'S Gloves
Cleared on Jan 9, 2019 after a 265-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 9, 2019
- Review
- 265 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. 2019, 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?
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below. Chemotherapy Drug permeation and concentration (Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves. Breakthrough Detection Time in Minutes Chemotherapy Drugs: White Glove…
Read the full statement (229 words)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Chemotherapy Drug permeation and concentration
(Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves.
Breakthrough Detection Time in Minutes
Chemotherapy Drugs: White Glove Blue Glove
1. Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 79.0 min 48.5 min
2. Cisplatin 1.0 mg/ml (1,000 ppm) >240 min >240 min
3. Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) >240 min >240 min
4. Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) >240 min >240 min
5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) >240 min >240 min
6. Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) >240 min >240 min
7. Fluorouracil 50.0 mg/ml (50,000 ppm) >240 min >240 min
8. Ifosfamide 50.0 mg/ml (50,000 ppm) >240 min >240 min
9. Methotrexate 25 mg/ml (25,000 ppm) >240 min >240 min
10. Mitomycin C 0.5 mg/ml (500 ppm) >240 min >240 min
11. Mitoxantrone 2.0 mg/ml (2,000 ppm) >240 min >240 min
12. Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) >240 min >240 min
13. Thio-Tepa 10.0 mg/ml (10,000 ppm) 79.2 min 169.4 min
14. Vincristine Sulfate 1.0 mg/ml (1,000 ppm) >240 min >240 min
Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181047: Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves 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/K181047
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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