510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Comfort Rubber Gloves Industries Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Jun 27, 2019 as substantially equivalent to K180476 (Comfort Rubber Gloves Industries Sdn. Bhd., 2018) after a 162-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Jun 27, 2019
- Review
- 162 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 backK162405 Powder Free Nitrile Examination Gloves Tested For Use With…Comfort Rubber Gloves Industries Sdn. Bhd. · 2017
- 1 generation backK180476 Powder Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2018
- This deviceK190080 Powder Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2019
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 | K162405 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2017 | — |
| −1 | K180476 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Comfort Rubber Gloves Industries Sdn. Bhd. | 2018 | — |
| 0 (this device) | K190080 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2019 | — |
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 |
|---|---|---|---|
| * | K180476 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsSummary page 4…or Use with Chemotherapy Drugs Labeling Claim (Green) Company: Comfort Rubber Gloves Industries Sdn. Bhd. 510(K) No.: K180476 4.0 Description of the Device: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drug… | 2018 |
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 15 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 6 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. 2019, 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 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use chemotherapy drugs. Tested drugs are as follows…
Read the full statement (139 words)
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use chemotherapy drugs. Tested drugs are as follows:
Average Breakthrough Detection Time (minutes)
Cisplatin 1.0 mg/ml ≥ 240
Cyclophosphamide (Cytoxan) 20 mg/ml ≥ 240
Dacarbazine (DTIC) 10.0 mg/ml ≥ 240
Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240
Etoposide (Toposar) 20.0 mg/ml ≥ 240
Fluorouracil 50.0 mg/ml ≥ 240
Paclitaxel (Taxol) 6.0 mg/ml ≥ 240
Please note that the following drugs have extremely low permeation time for
*Carmustine (BCNU) 3.3mg/ml - 54.1 (mins)
*Thiotepa 10.0 mg/ml - 16.0 (mins)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190080: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190080
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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