510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxter Glove Manufacturing Sdn Bhd · LZC Medical Glove, Specialty
Cleared on May 2, 2016 as substantially equivalent to K141982 (Wrp Asia Pacific Sdn. Bhd., 2015) after a 342-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- May 2, 2016
- Review
- 342 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042805 (2004). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 2 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 1 generation backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- This deviceK151390 Powder Free Nitrile Examination Gloves Tested For Use With…Maxter Glove Manufacturing Sdn Bhd · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −2 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −1 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| 0 (this device) | K151390 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs | Maxter Glove Manufacturing Sdn Bhd | 2016 | — |
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 LZC? 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 LZC device
- #1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 5 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 |
|---|---|---|---|
| * | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for…Summary page 4…Examination Gloves Tested for Use with Chemotherapy Drugs 510(k) Number K141982 Regulation Number 21 CFR 880.6250 Regulatory Name Patient Exami… | 2015 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- 6 other devices also cite its predicate K141982.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 2025
MAUDE reports naming product code LZC, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 166 | 1 | 0 |
| 2009 | 5 | 253 | 0 | 1 |
| 2010 | 5 | 68 | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 4 | 149 | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 258 | 0 | 5 |
| 2017 | 6 | 121 | 0 | 7 |
| 2018 | 6 | 105 | 0 | 6 |
| 2019 | 7 | 200 | 0 | 8 |
| 2020 | 3 | 167 | 0 | 1 |
| 2021 | 3 | 94 | 1 | 2 |
| 2022 | 7 | 85 | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
A powder free 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug and Concentration Minimum Breakthrough Detection…
Read the full statement (138 words)
A powder free 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard
Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Test Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Minutes)
Cisplatin, 1.0mg/ml >240
Cyclophosphamide (Cytoxan), 20mg/ml >240
Carmustine (BCNU), 3.3mg/ml 1.0
Dacarbazine (DTIC), 10.0mg/ml >240
Doxorubicin Hydrochloride, 2.0mg/ml >240
Etoposide (Toposar), 20.0mg/ml >240
Fluorouracil, 50.0mg/ml >240
Paclitaxel (Taxol), 6.0mg/ml >240
Thiotepa, 10.0mg/ml 31.3
Methotrexate ,25mg/ml >240
Mitomycin C, 0.5mg/ml >240
Vincristine Sulfate, 1.0mg/ml >240
Ifosfamide, 50.0mg/ml >240
Please note that the following drugs have low permeation time of less than 240 minutes:
Carmustine (BCNU), 3.3mg/ml: 1.0 minute
Thiotepa, 10.0mg/ml: 31.3 minutes
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/K151390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151390: Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151390
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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