510(k) · Cleared
ClearedNephron Nitrile Powder-Free Nitrile 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
Nephron Nitrile, LLC · LZA Polymer Patient Examination Glove
Cleared on Jun 6, 2023 as substantially equivalent to K223559 (Nephron Pharmaceuticals Corporation, 2023) after a 28-day review. Its family tree reaches back 9 generations to 2004. 2 later devices descend from it.
- Decided
- Jun 6, 2023
- Review
- 28 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K042805 (2004). 10 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 5 generations between
- 3 generations backK182600 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2018
- 2 generations backK213440 Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested…Luliang Hongruida Health Protection Technology Co., Ltd. · 2022
- 1 generation backK223559 Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For…Nephron Pharmaceuticals Corporation · 2023
- This deviceK231349 Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For…Nephron Nitrile, LLC · 2023
- Descendant · cites it directly · 0 of its ownK232654 Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black…Nephron Nitrile, LLC · 2024
- Descendant · cites it directly · 0 of its ownK233970 Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves…Nephron Nitrile, LLC · 2024
Show all 9 generations
- Root · 9 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 8 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 7 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 6 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 5 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- 4 generations backK173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2018
- 3 generations backK182600 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2018
- 2 generations backK213440 Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested…Luliang Hongruida Health Protection Technology Co., Ltd. · 2022
- 1 generation backK223559 Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For…Nephron Pharmaceuticals Corporation · 2023
- This deviceK231349 Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For…Nephron Nitrile, LLC · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −8 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −7 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −6 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −5 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| −4 | K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2018 | — |
| −3 | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs… | Better Care Plastic Technology Co., Ltd. | 2018 | — |
| −2 | 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 | — |
| 0 (this device) | K231349 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With… | Nephron Nitrile, LLC | 2023 | — |
| +1 | K232654 | Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use… | Nephron Nitrile, LLC | 2024 | — |
| +1 | 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 |
|---|---|---|
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K223559 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy…Summary page 4…amination Gloves (Tested For Use With Chemotherapy Drugs) 510(k) Number K223559 Regulatory Class Class-1 Product code LZA, LZC, OPJ Owner… | 2023 |
What descends from it? (2)
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 19 years and passes through 9 companies; a new generation was cleared every 12 months on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K232654 (Nephron Nitrile, LLC, 2024) 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. 2023, 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?
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by…
Read the full statement (217 words)
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Bleomycin Sulfate (15.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Mechlorethamine HCl (1.0 mg/ml)
Busulfan (6.0 mg/ml) Epirubicin HCl (2.0 mg/ml) Melphalan (5.0 mg/ml)
Carboplatin (10.0 mg/ml) Etoposide (20.0 mg/ml) Methotrexate (25.0 mg/ml)
Cisplatin (1.0 mg/ml) Fludarabine (25.0 mg/ml) Mitomycin C (0.5 mg/ml)
Cyclophosphamide (20.0 mg/ml) Fluorouracil (50.0 mg/ml) Mitoxantrone HCl (2.0 mg/ml)
Cytarabine (100.0 mg/ml) Gemcitabine (38.0 mg/ml) Paclitaxel (6.0 mg/ml)
Dacarbazine (10.0 mg/ml) Idarubicin HCl (1.0 mg/ml) Rituximab (10.0 mg/ml)
Daunorubicin HCl (5.0 mg/ml) Ifosfamide (50.0 mg/ml) Trisenox (1.0 mg/ml)
Docetaxel (10.0 mg/ml) Irinotecan (20.0 mg/ml) Vincristine Sulfate (1.0 mg/ml)
The following chemotherapy drugs have low permeation times:
Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes
Warning: Not for Use with: Carmustine, Thiotepa
The tested Opioid is:
Fentanyl Citrate Injection (100 mcg/2 mL). Permeation: no breakthrough up to 240 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231349: Nephron Nitrile Powder-Free Nitrile 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 6, 2026. https://510kreport.com/device/K231349
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