510(k) · Cleared
ClearedChemotherapy Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3A Glove Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Sep 29, 2023 as substantially equivalent to K190860 (Ever Growth (Vietnam) Co., Ltd., 2019) after a 185-day review. Its family tree reaches back 2 generations to 2019.
- Decided
- Sep 29, 2023
- Review
- 185 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K182176 (2019). No later device cites it as a predicate yet.
- Root · 2 generations backK182176 Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested…Pt. Medisafe Technologies · 2019
- 1 generation backK190860 Disposable Powder Free Nitrile Examination Glove, Tested For Use…Ever Growth (Vietnam) Co., Ltd. · 2019
- This deviceK230847 Chemotherapy Gloves3A Glove Sdn. Bhd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use… | Pt. Medisafe Technologies | 2019 | — |
| −1 | K190860 | Disposable Powder Free Nitrile Examination Glove, Tested For Use With… | Ever Growth (Vietnam) Co., Ltd. | 2019 | — |
| 0 (this device) | K230847 | Chemotherapy Gloves | 3A Glove Sdn. Bhd. | 2023 | — |
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 LZA? 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 LZA device
- #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 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 |
|---|---|---|---|
| * | K190860 | Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy…Summary page 6…ble Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy 1 of page 10 Chemotherapy Gloves K230847 Drugs, Orange Color 510(k) number: K190860 5.0 Device Description The subject device is single use, disposable gloves intended for medical purposes to be worn on the exam… | 2019 |
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 4 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 2 ancestors has a recall.
- 11 other devices also cite its predicate K190860.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LZA
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 2025
MAUDE reports naming product code LZA, 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 | 21 | 95 | 0 | 7 |
| 2008 | 18 | 97 | 0 | 2 |
| 2009 | 28 | 112 | 0 | 12 |
| 2010 | 31 | 97 | 0 | 12 |
| 2011 | 26 | 122 | 0 | 9 |
| 2012 | 33 | 110 | 0 | 11 |
| 2013 | 20 | 130 | 0 | 10 |
| 2014 | 27 | 197 | 0 | 8 |
| 2015 | 20 | 112 | 1 | 12 |
| 2016 | 30 | 171 | 1 | 25 |
| 2017 | 44 | 124 | 0 | 4 |
| 2018 | 22 | 178 | 0 | 3 |
| 2019 | 25 | 212 | 0 | 21 |
| 2020 | 30 | 101 | 0 | 4 |
| 2021 | 139 | 111 | 0 | 20 |
| 2022 | 146 | 111 | 0 | 19 |
| 2023 | 62 | 92 | 0 | 24 |
| 2024 | 30 | 89 | 0 | 76 |
| 2025 | 24 | 110 | 0 | 73 |
| 2026 | 15 | 103 | 3 | — |
What is it indicated for?
Chemotherapy Gloves is a disposable device intended for medical purpose that is worn on the examiner’s hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. The proposed device is non-sterile, with fern green, midnight black and sky blue three…
Read the full statement (312 words)
Chemotherapy Gloves is a disposable device intended for medical purpose that is worn on the examiner’s hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. The proposed device is non-sterile, with fern green, midnight black and sky blue three colors.
Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes (minutes)
Carboplatin 10 mg/ml(10,000 ppm) > 240 min.
Carmustine 3.3 mg/ml (3,300 ppm) Midnight black:32.6(33.2,32.6,33.0) min.
Sky blue:24.5(25.2,24.5,26.1) min
Fern Green:24.3(28.1,26.3,24.3) min.
Cisplatin 1.0 mg/ml(1,000 ppm) > 240 min.
Cyclophosphamide 20.0 mg/ml(20,000 ppm) > 240 min.
Dacarbazine 10 mg/ml (10,000 ppm) > 240 min.
Docetaxel 10 mg/ml (10,000 ppm) > 240 min.
Doxorubicin HCL 2.0 mg/ml(2,000 ppm) > 240 min.
Epirubicin HCI 2 mg/ml (2,000 ppm) > 240 min.
Etoposide 20 mg/ml (20,000 ppm) > 240 min.
Fluorouracil 50.0 mg/ml(50,000 ppm) > 240 min.
Gemcitabine 38 mg/ml (38,000 ppm) > 240 min.
Ifosfamice 50 mg/ml (50,000 ppm) > 240 min.
Ifinotecan 20 mg/ml (20,000 ppm) > 240 min.
Methotrexate 25 mg/ml (25,000 ppm) > 240 min.
Mitomycin 0.5 mg/ml (500 ppm) > 240 min.
Mitoxantrone HCI 2 mg/ml (2,000 ppm) > 240 min.
Oxaliplatin 5 mg/ml (5,000 ppm) > 240 min.
Paclitaxel 6.0 mg/ml(6,000 ppm) > 240 min.
Thio Tepa 10.0 mg/ml(10,000 ppm) Midnight black: 58.7(87.2,67.8,58.7)
Vincristine Sulfate
Please note that the following drugs have low permeation times:
1 mg/ml (1,000 ppm)
Sky blue: 77.3(77.3,85.8,79.8)
Fern Green: 67.9(68.4,67.9,79.2)
> 240 min.
Midnight black: Carmustine 3.3 mg/ml 32.6 Minutes (min.); Thio Tepa 10.0 mg/ml 58.7 Minutes (min.).
Sky blue: Carmustine 3.3 mg/ml 24.5 Minutes (min.); Thio Tepa 10.0 mg/ml 77.3 Minutes (min.).
Fern green: Carmustine 3.3 mg/ml 24.3 Minutes (min.); Thio Tepa 10.0 mg/ml 67.9 Minutes (min.).
Warning: Please do not use with Carmustine and Thiotepa.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230847: Chemotherapy Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230847
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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