510(k) · Cleared
ClearedDisposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anhui Xinyisheng Medical Technology Co.,Ltd · LZC Medical Glove, Specialty
Cleared on Jan 28, 2022 after a 115-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 28, 2022
- Review
- 115 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. 2022, 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?
This device is intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes: Cisplatin,1.0 mg/ml (1,000 ppm) Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) Dacarbazine,10.0 mg/ml (10,000 ppm) Doxorubicin…
Read the full statement (115 words)
This device is intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM D6978-05(2019):
The following drugs had NO breakthrough detected up to 240 minutes:
Cisplatin,1.0 mg/ml (1,000 ppm)
Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm)
Dacarbazine,10.0 mg/ml (10,000 ppm)
Doxorubicin HCI, 2.0 mg/ml (2,000 ppm)
Etoposide, 20.0 mg/ml (20,000 ppm)
Fluorouracil,50.0 mg/ml (50,000 ppm)
Paclitaxel,6.0 mg/ml (6,000 ppm)
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 23.9minutes
ThioTepa10.0 mg/ml (10,000 ppm),25.3 minutes
WARNING: Do not use Carmustine and Thiotepa
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K213325 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213325: Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213325
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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