510(k) · Cleared
ClearedPowder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yue Kang Anhui Medical Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Apr 8, 2024 as substantially equivalent to K220088 (Professional Latex Sdn Bhd, 2023) after a 96-day review. Its family tree reaches back 3 generations to 2019.
- Decided
- Apr 8, 2024
- Review
- 96 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K183287 (2019). No later device cites it as a predicate yet.
- Root · 3 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 2 generations backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- 1 generation backK220088 Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for…Professional Latex Sdn Bhd · 2023
- This deviceK240021 Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile…Yue Kang Anhui Medical Products Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −2 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| −1 | K220088 | Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with… | Professional Latex Sdn Bhd | 2023 | — |
| 0 (this device) | K240021 | Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested… | Yue Kang Anhui Medical Products Co., Ltd. | 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 |
|---|---|---|---|
| * | K220088 | Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy…Summary page 5…te Device Information: Professional Latex Sdn Bhd Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K220088) Product code LZA, LZC, QDO, OPJ. 4. Device Description: Powder Free Nitrile Examination Gloves 3.5, Blue Color, Non-Sterile,… | 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 5 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 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?
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and 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. 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…
Read the full statement (163 words)
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and 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.
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.
Test Chemotherapy drug are as followings:
Test Chemotherapy drug & Concentration Minimum Breakthrough Detection Time (Minutes)
Carmustine (BCNU) (3.3mg/ml) 1.3
Cisplatin (1mg/ml) >240
Cyclophosphamide (20mg/ml) >240
Dacarbazine (10.0 mg/ml) >240
Doxorubicin HCl (2 mg/ml) >240
Etoposide (20mg/ml) >240
Fluorouracil (50mg/ml) >240
Paclitaxel (6mg/ml) >240
Thiotepa (10mg/ml) 1.1
Test Fentanyl Citrate are as follows: Minimum Breakthrough Detection Time in minutes
Fentanyl Citrate Injection 100mcg/2ml >240
Warning: Do not use with Carmustine and Thiotepa.
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.3 minutes and
Thiotepa:1.1 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240021: Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240021
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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