510(k) · Cleared
ClearedBlack Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
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 Apr 15, 2020 as substantially equivalent to K183287 (Kossan International Sdn Bhd, 2019) after an 82-day review. Its family tree reaches back 1 generation to 2019. 1 later device descends from it.
- Decided
- Apr 15, 2020
- Review
- 82 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K183287 (2019). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- This deviceK200181 Black Colored Powder Free Nitrile Examination Gloves Tested for Use…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- Descendant · cites it directly · 0 of its ownK220609 Powder-Free Nitrile Examination Glove Tested for Use with…Encompass Industries Sdn. Bhd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220609Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and…Encompass Industries Sdn. Bhd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| 0 (this device) | K200181 | Black Colored Powder Free Nitrile Examination Gloves Tested for Use with… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| +1 | K220609 | Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs… | Encompass Industries Sdn. Bhd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use…Summary page 5…ove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Company: Kossan International Sdn. Bhd. Predicate 510(K) No.: K183287 4. Description of the Device: Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with… | 2019 |
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 |
|---|---|---|---|
| K220609 | Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and… | 2022 | 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?
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 Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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 and…
Read the full statement (174 words)
The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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 and Fentanyl Citrate. Tested chemotherapy drugs are as follows:
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
*Carmustine (BCNU) 3.3mg.ml 54.1 minutes)
*Thiotepa 10.0 mg/ml 6.0 (minutes)
*Please note that these drugs have extremely low permeation time
CAUTION: Testing showed an average breakthrough time of 54.1 minutes with Carmustine.
WARNING: Do not use with Thiotepa.
Tested Fentanyl Citrate is as follows: Average Breakthrough Detection Time (minutes)
Fentanyl Citrate Injection 100.0 mcg/2ml ≥ 240
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200181: Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200181
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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