510(k) · Cleared
ClearedPowder Free Nitrile Examination Glove, Non-Sterile, and 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
Professional Latex Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Mar 30, 2023 as substantially equivalent to K192954 (Comfort Rubber Gloves Industries Sdn. Bhd., 2020) after a 443-day review. Its family tree reaches back 2 generations to 2019. 1 later device descends from it.
- Decided
- Mar 30, 2023
- Review
- 443 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K183287 (2019). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 1 generation backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- This deviceK220088 Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for…Professional Latex Sdn Bhd · 2023
- Descendant · cites it directly · 0 of its ownK240021 Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile…Yue Kang Anhui Medical Products Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240021Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use…Yue Kang Anhui Medical Products Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −1 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| 0 (this device) | K220088 | Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with… | Professional Latex Sdn Bhd | 2023 | — |
| +1 | K240021 | Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested… | Yue Kang Anhui Medical Products Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and FentanylSummary page 5…ted for Use with Chemotherapy Drugs and Fentanyl Citrate. Company: Comfort Rubber Gloves Industries Sdn. Bhd Predicate 510(K) Number: K192954 4.0 Description of Device Powder Free Nitrile Examination Gloves, Non-Sterile, and Tested for Use with… | 2020 |
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 |
|---|---|---|---|
| K240021 | Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use… | 2024 | 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 4 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K240021 (Yue Kang Anhui Medical Products Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K192954.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Powder Free Nitrile Examination Gloves, Non-Sterile, and tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam gloves which is 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…
Read the full statement (191 words)
Powder Free Nitrile Examination Gloves, Non-Sterile, and tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam gloves which is 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 and Concentration: Cisplatin, 1.0 mg/ml > 240
Cyciophosphamide (Cytoxan), 20.0 mg/ml > 240
Dacarbazine, 10.0 mg/ml > 240
Doxorubicin HCI, 2.0 mg/ml > 240
Etoposide, 20.0 mg/ml > 240
Fluorouracil, 50.0 mg/ml > 240
Ifosfamide, 50.0 mg/ml > 240
Methotrexate, 25.0 mg/ml > 240
Mitomycin C, 0.5 mg/ml > 240
Mitoxantrone, 2.0 mg/ml > 240
Paclitaxel, 6.0 mg/ml > 240
Vincristine Sulfate, 1.0 mg/ml > 240
Carmustine (BCNU), 3.3 mg/ml 24.3
ThioTepa, 10.0 mg/ml 48.6
Fentanyl Citrate Injection 100.0 mcg/2ml > 240
WARNING.
Please note that the following drugs have extremely low permeation time:
Carmustine (BCNU), 3.3 mg/ml : 24.3 minutes and Thiotepa, 10.0 mg/ml : 48.6 minutes
Do not use with Carmustine and Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220088: Powder Free Nitrile Examination Glove, Non-Sterile, and 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/K220088
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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