510(k) · Cleared
ClearedPower Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
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 19, 2020 as substantially equivalent to K183287 (Kossan International Sdn Bhd, 2019) after a 242-day review. Its family tree reaches back 1 generation to 2019. 26 later devices descend from it.
- Decided
- Jun 19, 2020
- Review
- 242 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K183287 (2019). 26 later devices descend from it, 11 citing it directly.
- Root · 1 generation backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- This deviceK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- Descendant · cites it directly · 8 of its ownK221269 Powder Free Nitrile Examination Gloves (Blue),Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK232266 Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non…Better Care Plastic Technology Co., Ltd. · 2023
- Descendant · cites it directly · 3 of its ownK213408 BPG ChemoPlus Nitrile Patient Examination Gloves, Powder FreeMeditech Gloves Sdn Bhd · 2022
- Descendant · cites it directly · 2 of its ownK230779 Powder Free Nitrile Examination Gloves (Black), Tested for Use with…Shanxi Hongjin Plastic Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK230121 Nitrile Examination Gloves Powder Free Tested For Use With…Careglove Global Sdn. Bhd. · 2023
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K221269Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and…Better Care Plastic Technology Co., Ltd. · 2022 · cites it directly8descendants
- K232266Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for…Better Care Plastic Technology Co., Ltd. · 2023 · 2 generations on3descendants
- K213408BPG ChemoPlus Nitrile Patient Examination Gloves, Powder FreeMeditech Gloves Sdn Bhd · 2022 · cites it directly3descendants
- K230779Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs…Shanxi Hongjin Plastic Technology Co., Ltd. · 2023 · cites it directly2descendants
- K230121Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl…Careglove Global Sdn. Bhd. · 2023 · 2 generations on2descendants
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) | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| +1 | K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2022 | — |
| +2 | K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile… | Better Care Plastic Technology Co., Ltd. | 2023 | — |
| +1 | K213408 | BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free | Meditech Gloves Sdn Bhd | 2022 | — |
| +1 | K230779 | Powder Free Nitrile Examination Gloves (Black), Tested for Use with… | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023 | — |
| +2 | K230121 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs… | Careglove Global Sdn. Bhd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 10 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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…, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Company : Kossan International Sdn. Bhd. 510(K) No. : K183287 4.0 Description of the Device: Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use… | 2019 |
What descends from it? (26)
See all 2611 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and… | 2022 | 8 |
| K213408 | BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free | 2022 | 3 |
| K230779 | Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs… | 2023 | 2 |
| K240545 | GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs… | 2024 | 1 |
| K220088 | Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy… | 2023 | 1 |
| K223415 | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with… | 2023 | 0 |
| K222907 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and… | 2023 | 0 |
| K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And… | 2022 | 0 |
| K220401 | Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs… | 2022 | 0 |
| K212613 | Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy… | 2021 | 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 Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam 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. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of…
Read the full statement (183 words)
The Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam 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. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows: Average Breakthrough Detection Time (minutes)
Cisplatin 1.0 mg/ml ≥ 240
Cyclophosphamide (Cytoxan) 20 mg/ml ≥ 240
Dacarbazine (DTIC) l 0.0 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) -3.3 mg/ml 18.2
Thiotepa (THT) -10.0 mg/ml 57.3
Tested Fentanyl Citrate is as follows: Average Breakthrough Detection Time
Fentanyl Citrate Injection 100.0 mcg/2ml (minutes) ≥ 240
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 18.2 minutes and Thiotepa: 57.3 minutes. Warning: Do not use with Carmustine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192954: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192954
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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