510(k) Report

510(k) · Cleared

Cleared

Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)

K233970510(k) SpecialCleared Jan 16, 202432-day reviewClass I21 CFR 880.6250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nephron Nitrile, LLC · LZA Polymer Patient Examination Glove

Cleared on Jan 16, 2024 as substantially equivalent to K231349 (Nephron Nitrile, LLC, 2023) after a 32-day review. Its family tree reaches back 10 generations to 2004.

Decided
Jan 16, 2024
Review
32 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K042805 (2004). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestorK042805 · Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile · Perusahaan Getah Asas Sdn. Bhd. · 2004K081089 · Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim · Kimberly-Clark Corp. · 2008K141982 · Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs · Wrp Asia Pacific Sdn. Bhd. · 2015K163146 · POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs · Hebei Hongsen Plastics Technology Co, Ltd. · 2017K172525 · Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs · Central Medicare Sdn Bhd · 2017K173942 · Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs · Central Medicare Sdn Bhd · 2018K182600 · Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) · Better Care Plastic Technology Co., Ltd. · 2018K213440 · Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs · Luliang Hongruida Health Protection Technology Co., Ltd. · 2022K223559 · Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) · Nephron Pharmaceuticals Corporation · 2023K231349 · Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) · Nephron Nitrile, LLC · 2023200020052010201520202025
Other ancestors, by generation 10 generations back: 1 other ancestor K231349 · Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) · Nephron Nitrile, LLC · 2023K223559 · Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) · Nephron Pharmaceuticals Corporation · 2023K213440 · Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs · Luliang Hongruida Health Protection Technology Co., Ltd. · 2022K182600 · Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) · Better Care Plastic Technology Co., Ltd. · 2018K173942 · Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs · Central Medicare Sdn Bhd · 2018K172525 · Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs · Central Medicare Sdn Bhd · 2017K163146 · POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs · Hebei Hongsen Plastics Technology Co, Ltd. · 2017K141982 · Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs · Wrp Asia Pacific Sdn. Bhd. · 2015K081089 · Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim · Kimberly-Clark Corp. · 2008K042805 · Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile · Perusahaan Getah Asas Sdn. Bhd. · 2004−10−50
  1. Root · 10 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
  2. 6 generations between
  3. 3 generations backK213440 Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested…Luliang Hongruida Health Protection Technology Co., Ltd. · 2022
  4. 2 generations backK223559 Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For…Nephron Pharmaceuticals Corporation · 2023
  5. 1 generation backK231349 Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For…Nephron Nitrile, LLC · 2023
  6. This deviceK233970 Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves…Nephron Nitrile, LLC · 2024
Show all 10 generations
  1. Root · 10 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
  2. 9 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
  3. 8 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
  4. 7 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
  5. 6 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
  6. 5 generations backK173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2018
  7. 4 generations backK182600 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2018
  8. 3 generations backK213440 Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested…Luliang Hongruida Health Protection Technology Co., Ltd. · 2022
  9. 2 generations backK223559 Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For…Nephron Pharmaceuticals Corporation · 2023
  10. 1 generation backK231349 Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For…Nephron Nitrile, LLC · 2023
  11. This deviceK233970 Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves…Nephron Nitrile, LLC · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K042805Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-SterilePerusahaan Getah Asas Sdn. Bhd.2004—
−9K081089Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with…Kimberly-Clark Corp.2008—
−8K141982Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile…Wrp Asia Pacific Sdn. Bhd.2015—
−7K163146POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy DrugsHebei Hongsen Plastics Technology Co, Ltd.2017—
−6K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with…Central Medicare Sdn Bhd2017—
−5K173942Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with…Central Medicare Sdn Bhd2018—
−4K182600Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs…Better Care Plastic Technology Co., Ltd.2018—
−3K213440Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use…Luliang Hongruida Health Protection Technology Co., Ltd.2022—
−2K223559Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With…Nephron Pharmaceuticals Corporation2023—
−1K231349Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With…Nephron Nitrile, LLC2023—
0 (this device)K233970Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use…Nephron Nitrile, LLC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K233970, 2004–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K231349Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy…
Summary page 6
…Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) 510(k) Number K231349 Regulatory Class Class-1 Product code LZA, LZC, OPJ, QDO Manufacturer…
Nephron Nitrile, LLC2023—

Also cleared against K231349: 1 other device →

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 20 years and passes through 9 companies; a new generation was cleared every 12 months on median.
  • None of the 11 ancestors has a recall.
  • 1 other device also cites its predicate K231349.

How does its category compare?

All LZA devices

LZA 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

2007: 212008: 182009: 282010: 312011: 262012: 332013: 202014: 272015: 202016: 302017: 442018: 222019: 252020: 302021: 1392022: 1462023: 622024: 302025: 242026 (partial year): 15
2007high 146 (2022) · low 18 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZA

110in 2025

2007: 95 days median2008: 97 days median2009: 112 days median2010: 97 days median2011: 122 days median2012: 110 days median2013: 130 days median2014: 197 days median2015: 112 days median2016: 171 days median2017: 124 days median2018: 178 days median2019: 212 days median2020: 101 days median2021: 111 days median2022: 111 days median2023: 92 days median2024: 89 days median2025: 110 days median2026 (partial year): 103 days median
2007high 212 (2019) · low 89 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZA

3so far in 2026, the most since 2007

2015: 12016: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZA

73in 2025

2007: 72008: 22009: 122010: 122011: 92012: 112013: 102014: 82015: 122016: 252017: 42018: 32019: 212020: 42021: 202022: 192023: 242024: 762025: 73
2007high 76 (2024) · low 2 (2008)2025

MAUDE reports naming product code LZA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007219507
2008189702
200928112012
20103197012
20112612209
201233110011
201320130010
20142719708
201520112112
201630171125
20174412404
20182217803
201925212021
20203010104
2021139111020
2022146111019
20236292024
20243089076
202524110073
2026151033—

What is it indicated for?

Nephron Nitrile™, Nitrile Powder-Free Examination Blue 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…

Read the full statement (218 words)

Nephron Nitrile™, Nitrile Powder-Free Examination Blue 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)

Busulfan (6.0 mg/ml)

Carboplatin (10.0 mg/ml)

Cisplatin (1.0 mg/ml)

Cyclophosphamide (20.0 mg/ml)

Cytarabine (100.0 mg/ml)

Dacarbazine (10.0 mg/ml)

Daunorubicin HCl (5.0 mg/ml)

Docetaxel (10.0 mg/ml)

Doxorubicin HCl (2.0 mg/ml)

Epirubicin HCl (2.0 mg/ml)

Etoposide (20.0 mg/ml)

Fludarabine (25.0 mg/ml)

Fluorouracil (50.0 mg/ml)

Gemcitabine (38.0 mg/ml)

Idarubicin HCl (1.0 mg/ml)

Ifosfamide (50.0 mg/ml)

Irinotecan (20.0 mg/ml)

Mechlorethamine HCl (1.0 mg/ml)

Melphalan (5.0 mg/ml)

Methotrexate (25.0 mg/ml)

Mitomycin C (0.5 mg/ml)

Mitoxantrone HCl (2.0 mg/ml)

Paclitaxel (6.0 mg/ml)

Rituximab (10.0 mg/ml)

Trisenox (1.0 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.

Cite this page

510(k) Report. “K233970: Nephron Nitrile™, Nitrile Powder-Free Examination Blue 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/K233970

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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