510(k) · Cleared
ClearedNon-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yty Industry (Manjung) Sdn Bhd · LZC Medical Glove, Specialty
Cleared on Mar 19, 2019 after a 200-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 19, 2019
- Review
- 200 days
- Class
- Class I
- Product code
- LZC
- 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 LZC? 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 LZC device
- #1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 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 LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 2025
MAUDE reports naming product code LZC, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 166 | 1 | 0 |
| 2009 | 5 | 253 | 0 | 1 |
| 2010 | 5 | 68 | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 4 | 149 | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 258 | 0 | 5 |
| 2017 | 6 | 121 | 0 | 7 |
| 2018 | 6 | 105 | 0 | 6 |
| 2019 | 7 | 200 | 0 | 8 |
| 2020 | 3 | 167 | 0 | 1 |
| 2021 | 3 | 94 | 1 | 2 |
| 2022 | 7 | 85 | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. Tested Chemotherapy Drug And Concentration Average Breakthrough Detection Time Carboplatin, 10 mg/ml >240 minutes Carmustine 3.3 mg/ml 11.3 minutes Cisplatin (BCNU), 1.0 mg/ml > 240 minutes Cyclophosphamide (Cytoxan), 20.0 mg/ml > 240 minutes Dacarbazine (DTIC), 10.0 mg/ml >…
Read the full statement (153 words)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.
Tested Chemotherapy Drug And Concentration Average Breakthrough Detection Time
Carboplatin, 10 mg/ml >240 minutes
Carmustine 3.3 mg/ml 11.3 minutes
Cisplatin (BCNU), 1.0 mg/ml > 240 minutes
Cyclophosphamide (Cytoxan), 20.0 mg/ml > 240 minutes
Dacarbazine (DTIC), 10.0 mg/ml > 240 minutes
Doxorubicin Hydrochloride, 2.0 mg/ml > 240 minutes
Etoposide (Toposar), 20.0 mg/ml > 240 minutes
Fluorouracil, 50.0 mg/ml > 240 minutes
Ifosfamide , 50.0 mg/ml > 240 minutes
Methotrexate, 25 mg/ml > 240 minutes
Mitomycin C, 0.5 mg/ml > 240 minutes
Mitoxantrone, 2 mg/ml > 240 minutes
Paclitaxel (Taxol), 6.0 mg/ml > 240 minutes
ThioTEPA (10.0 mg/ml) 7.4minutes
Vincristine Sulfate, 1.0 mg/ml > 240 minutes
The following chemotherapy drugs and concentration have extremely low permeation time.
Carmustine (3.3 mg/ml): 11.3 minutes ThioTEPA (10.0 mg/ml): 7.4 minutes
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K182383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182383: Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182383
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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