510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lingshi Hongruida Health Protection Technology Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Feb 29, 2024 as substantially equivalent to K223320 (Lingshi Hongruida Health Protection Technology Co., Ltd., 2022) after a 52-day review. Its family tree reaches back 1 generation to 2022. 1 later device descends from it.
- Decided
- Feb 29, 2024
- Review
- 52 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K223320 (2022). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK223320 Powder Free Nitrile Examination Gloves (Blue), Tested for Use with…Lingshi Hongruida Health Protection Technology Co., Ltd. · 2022
- This deviceK240051 Powder Free Nitrile Examination Gloves (Blue), Tested For Use With…Lingshi Hongruida Health Protection Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK243441 Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…Basic Medical Technology, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243441Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl…Basic Medical Technology, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K223320 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K240051 | Powder Free Nitrile Examination Gloves (Blue), Tested For Use With… | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2024 | — |
| +1 | K243441 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid… | Basic Medical Technology, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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 |
|---|---|---|---|
| * | K223320 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs…Summary page 6…n: Lingshi Hongruida Health Protection Technology Co., Ltd. Powder Free Nitrile Examination Gloves (Blue)，Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K223320) 4. Device Description: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrat… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243441 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl… | 2025 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K243441 (Basic Medical Technology, Inc., 2025) has gone furthest, with 0 descendants of its own.
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 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, Fentanyl Citrate, and select other drugs using ASTM D6978-05(2019) The following chemicals have been tested with these gloves: Chemotherapy Drug Minimum Breakthrough Detection Time in Minutes Bleomycin Sulfate 15mg/ml (15000 ppm) >240 Busulfan…
Read the full statement (288 words)
The 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, Fentanyl Citrate, and select other drugs using ASTM D6978-05(2019)
The following chemicals have been tested with these gloves:
Chemotherapy Drug Minimum Breakthrough Detection Time in Minutes
Bleomycin Sulfate 15mg/ml (15000 ppm) >240
Busulfan 6mg/ml (6,000 ppm) >240
Carboplatin 10mg/ml (10,000 ppm) >240
Carmustine 3.3 mg/ml (3,300 ppm) 29.1
Cisplatin 1mg/ml (1,000 ppm) >240
Cyclophosphamide 20mg/ml (20,000 ppm) >240
Cytarabine, 100 mg/ml (100,000 ppm) >240
Dacarbazine 10 mg/ml (10,000 ppm) >240
Daunorubicin HCL, 5 mg/ml (5,000 ppm) >240
Docetaxel , 10 mg/ml (10,000 ppm) >240
Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240
Epirubicin HCL, 2 mg/ml (2,000 ppm) >240
Etoposide, 20 mg/ml (20,000 ppm) >240
Fludarabine Phosphate, 25 mg/ml (25,000 ppm) >240
Fluorouracil, 50mg/ml (50,000ppm) >240
Gemcitabine HCL, 38mg/ml (38,000ppm) >240
Idarubicin HCL, Img/ml (1,000ppm) >240
Ifosfamide, 5S0mg/ml (50,000ppm) >240
Irinotecan HCL, 20mg/m1l (20,000ppm) >240
Mechlorethamine HCI, Img/ml (1,000ppm) >240
Melphalan HCL, 5mg/ml (5,000ppm) >240
Methotrexate, 25mg/ml (25,000ppm) >240
Mitomycin C, 0.5mg/ml (500ppm) >240
Mitoxantrone HCL, 2mg/ml (2,000ppm) >240
Oxaliplatin, Smg/ml (5,000ppm) >240
Paclitaxel, 6mg/ml (6,000ppm) >240
Paraplatin, 10mg/ml (10,000ppm) >240
Rituximab, 10mg/ml (10,000ppm) >240
Thiotepa, 10mg/ml (10,000ppm) 78.3
Topotecan HCL, Img/ml (1,000ppm) >240
Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) >240
Velcade (Bortezomib), 1mg/ml (1,000ppm) >240
Vincristine Sulfate, 1mg/ml (1,000ppm) >240
Fentanyl Citrate & other drugs Minimum Breakthrough Detection Time in Minutes
Fentanyl Citrate Injection, 100mcg/2mg >240
Chloroquine 50mg/ml (50,000ppm) >240
Cyclosporin A 100 mg/ml (100,000 ppm) >240
Retrovir, 10mg/ml (10,000ppm) >240
*Please note that the following drugs have extremely low permeation times:
Carmustine: 29.1 minutes, Thiotepa: 78.3 minutes
Warning: 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/K240051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240051: Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240051
Report an extraction error
Are you the manufacturer?
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