510(k) · Cleared
ClearedKIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corporation · LZA Polymer Patient Examination Glove
Cleared on Apr 10, 2020 as substantially equivalent to K170686 (Brightway Holdings Sdn. Bhd., 2017) and 1 other predicate after an 87-day review. Its family tree reaches back 5 generations to 2000. 3 later devices descend from it.
- Decided
- Apr 10, 2020
- Review
- 87 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000323 (2000). 7 ancestors in all, the oldest K992162 (1999). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK000323 Nitrile Patient Examination Glove (Blue Color) Powder Free, Non…Siam Sempermed Corp., Ltd. · 2000
- 4 generations backK060753 Non-Sterile, Powder Free Nitrile Examination Glove, Blue with…Siam Sempermed Corp., Ltd. · 2006
- 3 generations backK080520 Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer…Siam Sempermed Corp., Ltd. · 2008
- 2 generations backK083755 Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue…Siam Sempermed Corp., Ltd. · 2009
- 1 generation backK182241 Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for…Sri Trang Gloves (Thailand) Co., Ltd. · 2019
- This deviceK200072 KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use…Kimberly-Clark Corporation · 2020
- Descendant · cites it directly · 0 of its ownK231435 KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for…Kimberly-Clark Corporation · 2023
- Descendant · cites it directly · 0 of its ownK231021 KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use…Kimberly-Clark Corporation · 2023
- Descendant · cites it directly · 0 of its ownK202416 Kimtech Prizm Multi-Layered Exam Glove Tested for use with…Kimberly Clark Corporation · 2020
Most influential descendants
Showing 3 of 3 · See all- K231435KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…Kimberly-Clark Corporation · 2023 · cites it directly0descendants
- K231021KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…Kimberly-Clark Corporation · 2023 · cites it directly0descendants
- K202416Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the…Kimberly Clark Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000323 | Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile | Siam Sempermed Corp., Ltd. | 2000 | — |
| −4 | K060753 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating… | Siam Sempermed Corp., Ltd. | 2006 | — |
| −3 | K080520 | Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with… | Siam Sempermed Corp., Ltd. | 2008 | — |
| −2 | K083755 | Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color… | Siam Sempermed Corp., Ltd. | 2009 | — |
| −1 | K182241 | Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with… | Sri Trang Gloves (Thailand) Co., Ltd. | 2019 | — |
| 0 (this device) | K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with… | Kimberly-Clark Corporation | 2020 | — |
| +1 | K231435 | KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with… | Kimberly-Clark Corporation | 2023 | — |
| +1 | K231021 | KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with… | Kimberly-Clark Corporation | 2023 | — |
| +1 | K202416 | Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs… | Kimberly Clark Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K170686 | Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy DrugsSummary page 6…ZA, QDO 1 of 8 4. Predicate Device: K170686: Brightway Non-Powdered Nitrile Examination Glove Tested for use with Chemotherapy gloves: LZA, LZC (Subject Glove is exactly t… | 2017 |
| * | K182241 | Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with…Summary page 6…Powdered Nitrile Examination Glove Tested for use with Chemotherapy gloves: LZA, LZC (Subject Glove is exactly the same glove, but seeking the additional QDO claim) K182241: Non-Sterile Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy gloves: LZA, LZC, QDO 5. Description… | 2019 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231435 | KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy… | 2023 | 0 |
| K231021 | KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy… | 2023 | 0 |
| K202416 | Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the… | 2020 | 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 20 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K231435 (Kimberly-Clark Corporation, 2023) has gone furthest, with 0 descendants of its own.
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 Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Test Results Follow: Chemotherapy Drug Concentration Minimum Breakthrough Detection Time Blenoxane (15mg/mL),(15,000 ppm) >240 Busulfan (6mg/mL),(6,000 ppm) >240 Carmustine (BiCNU) (3.3mg/mL),(3,300 ppm) >3.6 Cisplatin (lmg/mL),(1,000 ppm) >240…
Read the full statement (217 words)
The Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Test Results Follow:
Chemotherapy Drug Concentration Minimum Breakthrough Detection Time
Blenoxane (15mg/mL),(15,000 ppm) >240
Busulfan (6mg/mL),(6,000 ppm) >240
Carmustine (BiCNU) (3.3mg/mL),(3,300 ppm) >3.6
Cisplatin (lmg/mL),(1,000 ppm) >240
Cyclophosphamide/cytoxan (20mg/mL),(20,000 ppm) >240
Cytarabine (100mg/mL),(100,000 ppm) >240
Dacarbazine(DTIC) (10mg/mL),(10,000 ppm) >240
Daunorubicin (5mg/mL),(5,000 ppm) >240
Docetaxel (10mg/mL),(l 0,000ppm) >240
Doxorubicin (2mg/mL),(2,000 ppm) >240
Ellence (2mg/mL),(2,000 ppm) >240
Etoposide/Toposar (20mg/mL,(20,000 ppm) >240
Fludarabine (25mg/mL),(25,000 ppm) >240
Fluorouracil (50mg/mL),(50,000 ppm) >240
Gemcitabine (38mg/mL),(38,000 ppm) >240
Idarubicin (1mg/mL),(1,000 ppm) >240
Ifosfamide (50mg/mL),(50,000 ppm) >240
Irinotecan (20mg/mL),(20,000 ppm) >240
Mechlorethamine HCL (l mg/mL),(1,000 ppm) >240
Melphalan (5mg/mL),(5,000 ppm) >240
Methotrexate (25mg/mL),(25,000 ppm) >240
Mitomycin C (0.5mg/mL),(500 ppm) >240
Mitoxantrone (2mg/mL),(2,000 ppm) >240
Paclitaxel (6mg/mL),(6,000 ppm) >240
Paraplatin (10mg/mL),(10,000 ppm) >240
Rituximab (10mg/mL),(10,000 ppm) >240
Thiotepa (10mg/mL),(10,000 ppm) >15.9
Trisenox (0.l mg/mL),(100 ppm) >240
Vincristine Sulfate (l mg/ m ),(1,000 ppm) >240
The Fentanyl Citrate and Gastric acid tested as follows:
Fentanyl Citrate 100mcg/2mL >240
Gastric Acid (simulated) 0.2% NaCl in 0.7% HCL >240
Fentanyl in Gastric Acid 50/50 Mix >240
Note: Carmustine and Thiotepa have extremely low permeation times of 3.6 and 15.9 minutes respectively
Warning: Do Not Use With: Carmustine, Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200072 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200072: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200072
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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