510(k) · Cleared
ClearedNitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xingyu Medical Tech Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on May 28, 2024 as substantially equivalent to K232266 (Better Care Plastic Technology Co., Ltd., 2023) after an 83-day review. Its family tree reaches back 4 generations to 2019.
- Decided
- May 28, 2024
- Review
- 83 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K183287 (2019). No later device cites it as a predicate yet.
- Root · 4 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 3 generations backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- 2 generations backK221269 Powder Free Nitrile Examination Gloves (Blue),Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2022
- 1 generation backK232266 Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non…Better Care Plastic Technology Co., Ltd. · 2023
- This deviceK240629 Nitrile Disposable Examination Gloves, Tested for Use with…Xingyu Medical Tech Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −3 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| −2 | K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2022 | — |
| −1 | K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile… | Better Care Plastic Technology Co., Ltd. | 2023 | — |
| 0 (this device) | K240629 | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs… | Xingyu Medical Tech Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for…Summary page 6…lassification: Class I Product code: LZA, LZC, OPJ, QDO Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital C. Predicate device: Primary Predicate Device: K232266 Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Ci… | 2023 |
| † | K212578 | Nitrile disposable examination gloves | 2021 |
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 5 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K232266.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested drugs are: Chemotherapy drug Concentration Minimum Breakthrough Detection Time Bleomycin sulfate (15.0 mg/ml 15,000 ppm) 240 min Carboplatin (10.0 mg/ml 10,000 ppm) 240 min Carmustine (BCNU)…
Read the full statement (235 words)
The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested drugs are:
Chemotherapy drug Concentration Minimum Breakthrough Detection Time
Bleomycin sulfate (15.0 mg/ml 15,000 ppm) 240 min
Carboplatin (10.0 mg/ml 10,000 ppm) 240 min
Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 26.7
Cisplatin (1.0 mg/mL 1,000 ppm) 240 min
Cyclophosphamide (20.0 mg/mL 20,000 ppm) 240 min
Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) 240 min
Dacarbazine (10.0 mg/mL 10,000 ppm) 240 min
Doxorubicin HCL (2.0 mg/mL 2,000 ppm) 240 min
Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) 240 min
Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) 240 min
Idarubicin (1.0 mg/ml 1,000 ppm) 240 min
Ifosfamide (50.0 mg/mL 50,000 ppm) 240 min
Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) 240 min
Methotrexate (25.0 mg/mL 25,000 ppm) 240 min
Mitomycin C (0.5 mg/mL 500 ppm) 240 min
Mitoxantrone HCL (2.0 mg/mL 2,000 ppm 240 min
Paclitaxel (6.0 mg/mL 6,000 ppm) 240 min
Thiotepa (10.0 mg/mL 10,000 ppm) 37.6
Vincristine Sulfate (1.0 mg/mL 1,000 ppm 240 min
Non Chemotherapy Drug
MESNA (100.0 mg/mL 100,000 ppm) 240 min
Trisenox (1.0 mg/ml 1,000 ppm) 240 min
Fentanyl Citrate Injection (100 mcg/2mL) 240 min
Note: Carmustine and Thiotepa have extremely low permeation times of 26.7 and 37.6 minutes respectively.
Warning: Do Not Use with Carmustine, Thiotepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240629 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240629: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240629
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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