510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves (Violet, Black, Green), 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. · LZC Medical Glove, Specialty
Cleared on Feb 24, 2025 as substantially equivalent to K221269 (Better Care Plastic Technology Co., Ltd., 2022) after a 63-day review. Its family tree reaches back 3 generations to 2019.
- Decided
- Feb 24, 2025
- Review
- 63 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K183287 (2019). No later device cites it as a predicate yet.
- Root · 3 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 2 generations backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- 1 generation backK221269 Powder Free Nitrile Examination Gloves (Blue),Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2022
- This deviceK243959 Powder Free Nitrile Examination Gloves (Violet, Black, Green)…Lingshi Hongruida Health Protection Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −2 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| −1 | K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K243959 | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use… | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2025 | — |
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 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? (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 |
|---|---|---|---|
| * | K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and…Summary page 6…vice Information: Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K221269) 4. Device Description: Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs,… | 2022 |
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 6 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K221269.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
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 Other Select Drugs using ASTM D6978-05(2019) Chemotherapy Drug & Concentration Minimum Breakthrough Detection Time in Minutes Violet Black Green Bleomycin Sulfate 15mg/ml (15000 ppm) >240 >240 >240 Busulfan 6mg/ml (6,000 ppm)…
Read the full statement (374 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 Other Select Drugs using ASTM D6978-05(2019)
Chemotherapy Drug & Concentration Minimum Breakthrough Detection Time in Minutes
Violet Black Green
Bleomycin Sulfate 15mg/ml (15000 ppm) >240 >240 >240
Busulfan 6mg/ml (6,000 ppm) >240 >240 >240
Carboplatin 10mg/ml (10,000 ppm) >240 >240 >240
Carmustine 3.3 mg/ml (3,300 ppm) 15.3 12.6 11.7
Cisplatin 1mg/ml (1,000 ppm) >240 >240 >240
Cyclophosphamide 20mg/ml (20,000 ppm) >240 >240 >240
Cytarabine, 100 mg/ml (100,000 ppm) >240 >240 >240
Dacarbazine 10 mg/ml (10,000 ppm) >240 >240 >240
Daunorubicin HCL, 5 mg/ml (5,000 ppm) >240 >240 >240
Docetaxel , 10 mg/ml (10,000 ppm) >240 >240 >240
Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240 >240 >240
Epirubicin HCL, 2 mg/ml (2,000 ppm) >240 >240 >240
Etoposide, 20 mg/ml (20,000 ppm) >240 >240 >240
Fludarabine, 25 mg/ml (25,000 ppm) >240 >240 >240
Fluorouracil, 50mg/ml (50,000ppm) >240 >240 >240
Gemcitabine, 38mg/ml (38,000ppm) >240 >240 >240
Idarubicin HCL, 1mg/ml (1,000ppm) >240 >240 >240
Ifosfamide, 50mg/ml (50,000ppm) >240 >240 >240
Irinotecan HCL, 20mg/ml (20,000ppm) >240 >240 >240
Mechlorethamine HCI, 1mg/ml (1,000ppm) >240 >240 >240
Melphalan HCL, 5mg/ml (5,000ppm) >240 >240 >240
Methotrexate, 25mg/ml (25,000ppm) >240 >240 >240
Mitomycin C, 0.5mg/ml (500ppm) >240 >240 >240
Mitoxantrone HCL, 2mg/ml (2,000ppm) >240 >240 >240
Oxaliplatin, 5mg/ml (5,000ppm) >240 >240 >240
Paclitaxel, 6mg/ml (6,000ppm) >240 >240 >240
Paraplatin, 10mg/ml (10,000ppm) >240 >240 >240
Rituximab, 10mg/ml (10,000ppm) >240 >240 >240
Thiotepa, 10mg/ml (10,000ppm) 36.4 15.4 33.0
Topotecan HCL, 1mg/ml (1,000ppm) >240 >240 >240
Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) >240 >240 >240
Velcade (Bortezomib) 1mg/ml (1,000ppm) >240 >240 >240
Vincristine Sulfate, 1mg/ml (1,000ppm) >240 >240 >240
Fentanyl Citrate & Other Drugs Minimum Breakthrough Detection Time in Minutes
Violet Black Green
Fentanyl Citrate Injection, 100mcg/2mg >240 >240 >240
Chloroquine 50mg/ml (50,000ppm) >240 >240 >240
Cyclosporin A 100 mg/ml (100,000 ppm) >240 >240 >240
Retrovir, 10mg/ml (10,000ppm) >240 >240 >240
*Please note that the following drugs have extremely low permeation times:
Carmustine: 15.3 minutes, Thiotepa: 36.4 minutes (Violet);
Carmustine: 12.6 minutes, Thiotepa: 15.4 minutes (Black);
Carmustine: 11.7 minutes, Thiotepa: 33.0 minutes (Green);
Warning: Do not use with Carmustine and Thiotepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243959: Powder Free Nitrile Examination Gloves (Violet, Black, Green), 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/K243959
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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