510(k) · Cleared
ClearedBlue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eco Medi Glove Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Dec 28, 2023 as substantially equivalent to K171339 (Eco Medi Glove Sdn. Bhd., 2017) after an 84-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Dec 28, 2023
- Review
- 84 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042805 (2004). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 4 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 3 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 2 generations backK161187 EMG Blue Nitrile Examination Gloves Powder Free with Tested for use…Eco Medi Glove Sdn. Bhd. · 2016
- 1 generation backK171339 EMG Blue Nitrile Examination Gloves Powder free with tested for use…Eco Medi Glove Sdn. Bhd. · 2017
- This deviceK233405 Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs…Eco Medi Glove Sdn. Bhd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −4 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −3 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −2 | K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with… | Eco Medi Glove Sdn. Bhd. | 2016 | — |
| −1 | K171339 | EMG Blue Nitrile Examination Gloves Powder free with tested for use with… | Eco Medi Glove Sdn. Bhd. | 2017 | — |
| 0 (this device) | K233405 | Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and… | Eco Medi Glove Sdn. Bhd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 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 |
|---|---|---|---|
| * | K171339 | EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy…Summary page 7…LZC, OPJ, and QDO Page 1 of 9 4.0 Identification of The Legally Marketed Device: Predicate Device: K171339, EMG Blue Nitrile Examination Glove Powder Free with Chemotherapy Drugs. 5.0 Device Description The subject devic… | 2017 |
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 19 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K171339.
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?
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl test claim is a disposable device intended for medical purposes that are worn on the examiner’s hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use. In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Test claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to…
Read the full statement (242 words)
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl test claim is a disposable device intended for medical purposes that are worn on the examiner’s hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Test claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs and Fentanyl Test claim
Chemotherapy Drug and Fentanyl Test Claim Concentration Minimum Breakthrough detection time in Minutes, ug/cm2/minute
1) Carmustine (3.3mg/ml or 3000ppm), 24.0 minutes
2) Cyclophosphamide (20mg/ml or 20,000ppm), >240 minutes
3) Cisplatin (1.0mg/ml or 1,000ppm), >240 minutes
4) Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), >240 minutes
5) Etoposide (20mg/ml or 20,000ppm), >240 minutes
6) Flourouracil (50mg/ml or 50,000), >240 minutes
7) Methorexate (25mg/ml or 25,000ppm), >240 minutes
8) Paclitaxel (6mg/ml or 6,000ppm), >240 minutes
9) Thiotepa (10mg/ml or 10,000ppm), 56.9 minutes
10) Ifosfamide (50mg/ml) >240 minutes
11) Mitoxantrone (2mg/ml) , >240 minutes
12) Vincristine Sulfate (1mg/ml) , >240 minutes
13) Carboplatin (10.0mg/ml), >240 minutes
14) Dacarbazine (DTIC) (10.0mg/ml) >240 minutes
15) Mitomicin C (0.5mg/ml) >240 minutes
16) Fentanyl Citrate Injection 100mg/2ml >240 minutes
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time.
Carmustine (BCNU) (3.3mg/ml)- Minimum Breakthrough detection time 24.0 ug/cm2/minute.
Thiotepa (10ug/ml) — Minimum Breakthrough detection time 56.9 ug/cm2/minute.
WARNING: Not for use with Carmustine and ThioTepa
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/K233405 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233405: Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233405
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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