510(k) · Cleared
ClearedNitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Careglove Global Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Apr 1, 2025 as substantially equivalent to K230121 (Careglove Global Sdn. Bhd., 2023) after a 33-day review. Its family tree reaches back 4 generations to 2019.
- Decided
- Apr 1, 2025
- Review
- 33 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K183287 (2019). No later device cites it as a predicate yet.
- Root · 4 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 3 generations backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- 2 generations backK213408 BPG ChemoPlus Nitrile Patient Examination Gloves, Powder FreeMeditech Gloves Sdn Bhd · 2022
- 1 generation backK230121 Nitrile Examination Gloves Powder Free Tested For Use With…Careglove Global Sdn. Bhd. · 2023
- This deviceK250578 Nitrile Examination Gloves Powder Free Tested for Use With…Careglove Global Sdn. Bhd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −3 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| −2 | K213408 | BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free | Meditech Gloves Sdn Bhd | 2022 | — |
| −1 | K230121 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs… | Careglove Global Sdn. Bhd. | 2023 | — |
| 0 (this device) | K250578 | Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs… | Careglove Global Sdn. Bhd. | 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 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 |
|---|---|---|---|
| * | K230121 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl…Summary page 5…21 CFR 880.6250 Predicate Device Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs & Fentanyl Citrate (Blue & Black), 510(K) number K230121 product code LZA, LZC, QDO, OPJ. Device Description Non-Sterile Nitrile Patient Examination Glove is made from synthetic rub… | 2023 |
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 1.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K230121.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
A patient examination glove 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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Table below shows the Summary Test Result for Resistance of Nitrile…
Read the full statement (260 words)
A patient examination glove 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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Table below shows the Summary Test Result for Resistance of Nitrile Powder Free Examination Glove (Blue & Black) to Permeation by Chemotherapy Drugs and Fentanyl Citrate.
Chemotherapy Drugs and Fentanyl Citrate — Concentration — Minimum Breakthrough Detection Time (minutes): Blue; Black
*Carmustine (BCNU) — 3.3 mg/ml — 22.6; 21.8
Cisplatin — 1.0 mg/ml — >240 min; >240 min
Cyclophosphamide (Cytoxan) — 20.0 mg/ml — >240 min; >240 min
Dacarbazine — 10.0 mg/ml — >240 min; >240 min
Doxorubicin HCL — 2.0 mg/ml — >240 min; >240 min
Etoposide — 20.0 mg/ml — >240 min; >240 min
Fluorouracil — 50.0 mg/ml — >240 min; >240 min
Ifosfamide — 50.0 mg/ml — >240 min; >240 min
Mitoxantrone — 2 mg/ml — >240 min; >240 min
Paclitaxel — 6.0 mg/ml — >240 min; >240 min
*Thio Tepa — 10.0 mg/ml — 43.9; 17.7
Vincristine Sulfate — 1.0 mg/ml — >240 min; >240 min
Methotrexate — 25.0 mg/ml — >240 min; >240 min
Mitomycin C. — 0.5 mg/ml — >240 min; >240 min
Fentanyl Citrate — 100mcg/2ml — >240 min; >240 min
*Please note that following drugs have extremely low permeation times:
1. Carmustine (BCNU)
2. Thio Tepa
Warning: Do not use with Carmustine and Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250578: Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250578
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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