510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kanglongda Vietnam Protection Technology Company Limited · LZA Polymer Patient Examination Glove
Cleared on Aug 2, 2024 as substantially equivalent to K202356 (Kanglongda Vietnam Protection Technology Company Limited, 2021) after a 28-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Aug 2, 2024
- Review
- 28 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K993247 (1999). No later device cites it as a predicate yet.
- Root · 6 generations backK993247 Nitrile Powder Free Patient Examination GlovesJda Intl., Inc. · 1999
- 5 generations backK082598 Powder Free Blue Patient Nitrile Examination GloveTangshan Zhonghong Pulin Group Co., Ltd. · 2009
- 4 generations backK121992 Powder-Free Nitrile Patient Examination Gloves, Blue ColorXinwei (Shandong) Plastic and Rubber Products Co., · 2012
- 3 generations backK131440 Powder Free Nitrile Patient Examination Gloves, BlueHebei Hongsen Plastics Technology Co, Ltd. · 2013
- 2 generations backK150340 POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES…Hebei Hongsen Plastics Technology Co, Ltd. · 2015
- 1 generation backK202356 Powder free Nitrile Examination Gloves (Blue, Violet Blue, White…Kanglongda Vietnam Protection Technology Company Limited · 2021
- This deviceK241970 Powder Free Nitrile Examination Gloves (Blue), Tested for Use with…Kanglongda Vietnam Protection Technology Company Limited · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K993247 | Nitrile Powder Free Patient Examination Gloves | Jda Intl., Inc. | 1999 | — |
| −5 | K082598 | Powder Free Blue Patient Nitrile Examination Glove | Tangshan Zhonghong Pulin Group Co., Ltd. | 2009 | — |
| −4 | K121992 | Powder-Free Nitrile Patient Examination Gloves, Blue Color | Xinwei (Shandong) Plastic and Rubber Products Co., | 2012 | — |
| −3 | K131440 | Powder Free Nitrile Patient Examination Gloves, Blue | Hebei Hongsen Plastics Technology Co, Ltd. | 2013 | — |
| −2 | K150340 | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue)… | Hebei Hongsen Plastics Technology Co, Ltd. | 2015 | — |
| −1 | K202356 | Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) | Kanglongda Vietnam Protection Technology Company Limited | 2021 | — |
| 0 (this device) | K241970 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Kanglongda Vietnam Protection Technology Company Limited | 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 |
|---|---|---|---|
| * | K202356 | Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)Summary page 6…1 510k Summary 5. Predicate Device Identification Predicate Device: 510(k) Number: K202356 Product Name: Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) Manufacturer: Kanglongd… | 2021 |
| † | K240629 | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | 2024 |
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 25 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- None of the 6 ancestors has a 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. 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 Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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 chemotherapy drugs are: Carmustine 3.3 mg/ml(3,300 ppm) 27.7 (35.5,27.7,27.7) Cisplatin 1 mg/ml (1,000 ppm) >240min Cyclophosphamide 20 mg/ml (20,000 ppm) >240min Dacarbazine 10mg/ml…
Read the full statement (165 words)
The Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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 chemotherapy drugs are:
Carmustine 3.3 mg/ml(3,300 ppm) 27.7
(35.5,27.7,27.7)
Cisplatin 1 mg/ml (1,000 ppm) >240min
Cyclophosphamide 20 mg/ml (20,000 ppm) >240min
Dacarbazine 10mg/ml (10,000 ppm) >240min
Doxorubicin HCI 2 mg/ml(2,000 ppm) >240min
Etoposide 20 mg/ml (20,000 ppm) >240min
Fluorouracil 50mg/ml(50,000 ppm) >240min
Gemcitabine HCl 38 mg/ml (38,000 ppm) >240min
Ifosfamide 50mg/ml (50,000 ppm) >240min
Methotrexate 25mg/ml (25,000 ppm) >240min
Mitomycin C 0.5 mg/ml(500 ppm) >240min
Mitoxantrone HCl 2 mg/ml (2,000 ppm) >240min
Paclitaxel 6 mg/ml (6,000 ppm) >240min
Thiotepa 10 mg/ml (10,000 ppm) 59.4(67.5,59.4,65.9)
Vincristine Sulfate 1 mg/ml (1,000 ppm) >240min
The tested non-chemotherapy drugs are:
Fentanyl Citrate injection 100mcg/2ml >240min
Note: Carmustine and Thiotepa have extremely low permeation times of 27.7 and 59.4 minutes respectively.
Warning: Do Not Use with Carmustine, Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241970: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241970
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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