510(k) · Cleared
ClearedPowder-free 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
Motex Healthcare (Anhui) Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on May 23, 2022 after a 124-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 23, 2022
- Review
- 124 days
- Class
- Class I
- Product code
- LZA
- 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 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?
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 LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Permeation: Chemotherapy Drugs Tested — Breakthrough Time Bleomycin…
Read the full statement (340 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug Permeation:
Chemotherapy Drugs Tested — Breakthrough Time
Bleomycin Sulfate, 15 mg/mI (15,000 ppm) — >240 minutes
Bortezomib (Velcade), I mg/mi (1,000ppm) — >240 minutes
Busulfan, 6 mg/mI (6,000 ppm) — >240 minutes
Carboplatin, 10 mg/mI (10,000 ppm) — >240 minutes
Carmustine (BCNU), 3.3 mg/mI (3,300 ppm) — 45 4 minutes*
Chloroquine, 50 mg/nil (50,000 ppm) — >240 minutes
Cisplatin, 1.0 mg/mI (1,000 ppm) — >240 minutes
Cyclophosphamide (Cytoxan), 20.0 mg/mI (20,000 ppm) — >240 minutes
Cytarabine, 100 mg/ml (100,000 ppm) — >240 minutes
Dacarbazine, 10.0 mg/mi (10,000 ppm) — >240 minutes
Daunorubicin HCI, 5 mg/mI (5,000 ppm) — >240 minutes
Docetaxel. 10 mg/mI (10,000 ppm) — >240 minutes
Etoposide, 20.0 mglml (20,000 ppm) — >240 minutes
Fluorouracil, 50 0 mg/mI (50,000 ppm) — >240 minutes
Gemcitabine, 38 mg/ml (38,000 ppm) — >240 minutes
Idarubicin HCI, 1 mg/ml (1,000 ppm) — >240 minutes
Ifosfamide, 50 mg/ml (50,000 ppm) — >240 minutes
Irinotecan, 20 mg/ml (20,000 ppm) — >240 minutes
Mechlorethamine HCI, I mg/ml (1,000 ppm) — >240 minutes
Melphalan, 5 mg/mI (5,000 ppm) — >240 minutes
Methotrexate, 25 mg/ml (25,000ppm) — >240 minutes
Mitomycin C, 0.5 mg/ml (500 ppm) — >240 minutes
Mitoxantrone, 2 mg/mI (2,000 ppm) — >240 minutes
Paclitaxel, 6.0 mg/ml (6,000 ppm) — >240 minutes
ThioTepa, 10.0 mg/mI (10,000 ppm) — 15.6 minutes*
Triclosan, 2 mg/mI (2,000 ppm) — >240 minutes
Trisenox, I mg/ml (1,000 ppm) — >240 minutes
Vincristine Sulfate, 1 0 mg/ml (1,000 ppm) — >240 minutes
*WARNING Not recommended for use with Carmustine and ThioTepa.
The maximum testing time is 240 minutes. Please note that the following drugs have low permeation times:
Carmustine (BCNU), 3.3 mg/mI (3,300 ppm) — 45.4 minutes
ThioTepa, 10.0 mg/ml (10,000 ppm) — 15.6 minutes
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K220155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220155: Powder-free 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 6, 2026. https://510kreport.com/device/K220155
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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