510(k) · Cleared
ClearedGEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
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 Mar 20, 2020 as substantially equivalent to K152542 (Riverstone Resources Sdn Bhd, 2015) after a 129-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Mar 20, 2020
- Review
- 129 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K022765 (2002). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
- 3 generations backK110921 Nitrile Powder-Free Examination Gloves Tested for Use with…Cardinal Health, Inc. · 2011
- 2 generations backK141623 Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug…Eco Medi Glove Sdn. Bhd. · 2014
- 1 generation backK152542 Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis…Riverstone Resources Sdn Bhd · 2015
- This deviceK193121 GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential…Eco Medi Glove Sdn. Bhd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K022765 | Nitrile Powder-Free Examination Gloves | Allegiance Healthcare Corp. | 2002 | — |
| −3 | K110921 | Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs | Cardinal Health, Inc. | 2011 | — |
| −2 | K141623 | Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim | Eco Medi Glove Sdn. Bhd. | 2014 | — |
| −1 | K152542 | Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential… | Riverstone Resources Sdn Bhd | 2015 | — |
| 0 (this device) | K193121 | GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and… | Eco Medi Glove Sdn. Bhd. | 2020 | — |
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 |
|---|---|---|---|
| * | K152542 | Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and…Summary page 5…Claim and tested for use with Chemotherapy Drugs, Powder Free, LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250. Predicate Device: K152542, Powder Free Nitrile Examination (Blue) with Low Dermatitis Potential Claim with tested for use with Chemotherapy Drugs 5.0… | 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 18 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K152542.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Gen 2 Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs. Chemotherapy Drugs and Concentration…
Read the full statement (177 words)
The Gen 2 Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.
Chemotherapy Drugs and Concentration Minimum Breakthrough detection time in minutes(jtg/cm®minute)
DCarmustine (BCNU)(3.3 mg/ml)(3,300ppm) 22
2)Cisplatin (1.0 mg/mI)(1,000ppm) No breakthrough up to 240 min
3)Cyclophosphamide (Cytoxan)(20 mg/m1)(20,000ppm) No breakthrough up to 240 min
4)Methotexale (25mg/ml)(25,000ppm) No breakthrough up to 240 min
5)Doxorubicin Hydrochloride (2.0 mg/m1)(2,000ppm) No breakthrough up 1o 240 min
6)Etoposide (Toposar)}(20.0 mg/ml)(20,000ppm) No breakthrough up to 240 min
TFluorouracit (50.0 mg/ml)(50,000ppm) No breakthrough up to 240 min
8)Paclitaxel (Taxol}(6.0 mg/mi}(6,000ppm) No breakthrough up to 240 min
9YThiotepa (10.0 mg/m!)(10,000ppm) . 474
The Maximum testing time is 240 minutes. Please note that the following drugs have low permeation time:
[)Carmustine (BCNU)(3.3mg/ml)with Permeation time of 22 minutes.
2)Thiotepa ( 10.0mg/ml)with Permeation time of 47.4 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/K193121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193121: GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193121
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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