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
Comfort Rubber Gloves Industries Sdn. Bhd. · LZC Medical Glove, Specialty
Cleared on May 15, 2018 as substantially equivalent to K162405 (Comfort Rubber Gloves Industries Sdn. Bhd., 2017) after an 82-day review. Its family tree reaches back 4 generations to 2004. 1 later device descends from it.
- Decided
- May 15, 2018
- Review
- 82 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042805 (2004). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 3 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 2 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 1 generation backK162405 Powder Free Nitrile Examination Gloves Tested For Use With…Comfort Rubber Gloves Industries Sdn. Bhd. · 2017
- This deviceK180476 Powder Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2018
- Descendant · cites it directly · 0 of its ownK190080 Powder Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190080Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling…Comfort Rubber Gloves Industries Sdn. Bhd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −3 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −2 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −1 | K162405 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2017 | — |
| 0 (this device) | K180476 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Comfort Rubber Gloves Industries Sdn. Bhd. | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K162405 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling…Summary page 4…e with Chemotherapy Drugs Labeling Claim (White) Company : Comfort Rubber Gloves Industries Sdn. Bhd. 510(K) No. : K162405 4.0 Description of the Device: The proposed device is the Powder Free Nitrile Examination Gloves Tested for Use with… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190080 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling… | 2019 | 0 |
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 14 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K190080 (Comfort Rubber Gloves Industries Sdn. Bhd., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) 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 (137 words)
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) 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 — 23.4 (mins)
*Thiotepa 10.0 mg/ml - 16.2 (mins)
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/K180476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180476: 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/K180476
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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