510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luliang Hongruida Health Protection Technology Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Feb 18, 2022 as substantially equivalent to K182600 (Better Care Plastic Technology Co., Ltd., 2018) after a 116-day review. Its family tree reaches back 7 generations to 2004. 5 later devices descend from it.
- Decided
- Feb 18, 2022
- Review
- 116 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K042805 (2004). 8 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 6 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 5 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 4 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 3 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- 2 generations backK173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2018
- 1 generation backK182600 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2018
- This deviceK213440 Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested…Luliang Hongruida Health Protection Technology Co., Ltd. · 2022
- Descendant · cites it directly · 3 of its ownK223559 Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For…Nephron Pharmaceuticals Corporation · 2023
- Descendant · 2 generations on · 2 of its ownK231349 Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For…Nephron Nitrile, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK232654 Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black…Nephron Nitrile, LLC · 2024
- Descendant · cites it directly · 0 of its ownK240072 Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested…Luliang Hongruida Health Protection Technology Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK233970 Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves…Nephron Nitrile, LLC · 2024
Most influential descendants
Showing 5 of 5 · See all- K223559Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy…Nephron Pharmaceuticals Corporation · 2023 · cites it directly3descendants
- K231349Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy…Nephron Nitrile, LLC · 2023 · 2 generations on2descendants
- K232654Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With…Nephron Nitrile, LLC · 2024 · 3 generations on0descendants
- K240072Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With…Luliang Hongruida Health Protection Technology Co., Ltd. · 2024 · cites it directly0descendants
- K233970Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With…Nephron Nitrile, LLC · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −6 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −5 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −4 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −3 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| −2 | K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2018 | — |
| −1 | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs… | Better Care Plastic Technology Co., Ltd. | 2018 | — |
| 0 (this device) | K213440 | Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use… | Luliang Hongruida Health Protection Technology Co., Ltd. | 2022 | — |
| +1 | K223559 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With… | Nephron Pharmaceuticals Corporation | 2023 | — |
| +2 | K231349 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With… | Nephron Nitrile, LLC | 2023 | — |
| +3 | K232654 | Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use… | Nephron Nitrile, LLC | 2024 | — |
| +1 | K240072 | Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use… | Luliang Hongruida Health Protection Technology Co., Ltd. | 2024 | — |
| +3 | K233970 | Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use… | Nephron Nitrile, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)Summary page 6…Class I 3. Predicate Device Information: Better Care Plastic Technology Co., Ltd Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) (K182600) 4. Device Description: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs Are C… | 2018 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K223559 (Nephron Pharmaceuticals Corporation, 2023) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K182600.
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?
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs 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 using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results. The following chemicals have been tested with these…
Read the full statement (486 words)
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs 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 using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.
The following chemicals have been tested with these gloves:
For Blue gloves:
Chemotherapy Drug Minimum BDT (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) 25.5
Chloroquine 50mg/ml (50,000ppm) >240
Cisplatin 1mg/ml (1,000 ppm) >240
Cyclophosphamide 20mg/ml (20,000 ppm) >240
Cyclosporin 100 mg/ml (100,000 ppm) >240
Cytarabine HCL, 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 HCL, 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, 25 mg/ml (25,000 ppm) >240
Fluorouracil, 50mg/ml (50,000ppm) >240
Gemcitabine, 38mg/ml (38,000ppm) >240
Idarubicin HCL, Img/ml (1,000ppm) >240
Ifosfamide, 50mg/ml (50,000ppm) >240
Irinotecan, 20mg/ml (20,000ppm) >240
Mechlorethamine HCI, Img/ml (1,000ppm) >240
Melphalan, Smg/ml (5,000ppm) >240
Methotrexate, 25mg/ml (25,000ppm) >240
Mitomycin, 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/Carboplatin, 10mg/ml (10,000ppm) >240
Retrovir, 10mg/ml (10,000ppm) >240
Rituximab, 10mg/ml (10,000ppm) >240
Thiotepa, 10mg/ml (10,000ppm) 66.8
Topotecan, 1mg/ml (1,000ppm) >240
Trisenox, 1mg/ml (1,000ppm) >240
Velcade (Bortezomib) , Img/ml (1,000ppm) >240
Vincristine Sulfate, 1mg/ml (1,000ppm) >240
* Please note that the following drugs have extremely low permeation times:
Carmustine: 25.5 minutes, Thiotepa: 66.8 minutes
For Purple-Blue gloves:
Chemotherapy Drug Minimum BDT (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) 21.2
Chloroquine 50mg/ml (50,000ppm) >240
Cisplatin 1mg/ml (1,000 ppm) >240
Cyclophosphamide 20mg/ml (20,000 ppm) >240
Cyclosporin 100 mg/ml (100,000 ppm) >240
Cytarabine HCL, 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 HCL, 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, 25 mg/ml (25,000 ppm) >240
Fluorouracil, 50mg/ml (50,000ppm) >240
Gemcitabine, 38mg/ml (38,000ppm) >240
Idarubicin HCL, Img/ml (1,000ppm) >240
Ifosfamide, 50mg/ml (50,000ppm) >240
Irinotecan, 20mg/ml (20,000ppm) >240
Mechlorethamine HCI, 1mg/ml (1,000ppm) >240
Melphalan, 5Smg/ml (5,000ppm) >240
Methotrexate, 25mg/ml (25,000ppm) >240
Mitomycin, 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/Carboplatin, 10mg/ml (10,000ppm) >240
Retrovir, 10mg/ml (10,000ppm) >240
Rituximab, 10mg/ml (10,000ppm) >240
Thiotepa, 10mg/ml (10,000ppm) 36.3
Topotecan, 1mg/ml (1,000ppm) >240
Trisenox, 1mg/ml (1,000ppm) >240
Velcade (Bortezomib) , 1mg/ml (1,000ppm) >240
Vincristine Sulfate, 1mg/ml (1,000ppm) >240
* Please note that the following drugs have extremely low permeation times:
Carmustine: 21.2 minutes, Thiotepa: 36.3 minutes
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/K213440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213440: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), 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/K213440
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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