510(k) · Cleared
ClearedKimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated 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 Nov 30, 2020 as substantially equivalent to K200072 (Kimberly-Clark Corporation, 2020) after a 98-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Nov 30, 2020
- Review
- 98 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000323 (2000). 8 ancestors in all, the oldest K992162 (1999). No later device cites it as a predicate yet.
- Root · 6 generations backK000323 Nitrile Patient Examination Glove (Blue Color) Powder Free, Non…Siam Sempermed Corp., Ltd. · 2000
- 5 generations backK060753 Non-Sterile, Powder Free Nitrile Examination Glove, Blue with…Siam Sempermed Corp., Ltd. · 2006
- 4 generations backK080520 Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer…Siam Sempermed Corp., Ltd. · 2008
- 3 generations backK083755 Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue…Siam Sempermed Corp., Ltd. · 2009
- 2 generations backK182241 Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for…Sri Trang Gloves (Thailand) Co., Ltd. · 2019
- 1 generation backK200072 KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use…Kimberly-Clark Corporation · 2020
- This deviceK202416 Kimtech Prizm Multi-Layered Exam Glove Tested for use with…Kimberly Clark Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000323 | Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile | Siam Sempermed Corp., Ltd. | 2000 | — |
| −5 | K060753 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating… | Siam Sempermed Corp., Ltd. | 2006 | — |
| −4 | K080520 | Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with… | Siam Sempermed Corp., Ltd. | 2008 | — |
| −3 | K083755 | Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color… | Siam Sempermed Corp., Ltd. | 2009 | — |
| −2 | K182241 | Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with… | Sri Trang Gloves (Thailand) Co., Ltd. | 2019 | — |
| −1 | K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with… | Kimberly-Clark Corporation | 2020 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…Summary page 8…3 of 8 Subject Gloves Technological Characteristics Comparison Table Predicate K200072 & K202416 Subject Gloves: Standard & Xtra Length Subject Glove 1 Sub… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K200072.
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?
CHEMICAL CONCENTRATION STANDARD LENGTH Cabazitaxel 60 mg/1.5ml (40,000 ppm) >240 min. Capecitabine 26 mg/ml (26,000 ppm) >240 min. Carmustine 3.3 mg/ml (3,300 ppm) 47.5 min. Cisplatin 1 mg/ml (1,000 ppm) >240 min. Cyclophosphamide 20 mq/ml (20,000 ppm) >240 min. Dacarbazine 10 mg/ml (10,000 ppm) >240 min. Doxorubicin HCL 2 mq/ml (2,000 ppm) >240 min. Eribulin Mesylate 0.5 mg/ml (500 ppm) >240 min. Etoposide 20 mq/ml (20,000 ppm) >240 min. Floxuridine 100…
Read the full statement (409 words)
CHEMICAL CONCENTRATION STANDARD LENGTH
Cabazitaxel 60 mg/1.5ml (40,000 ppm) >240 min.
Capecitabine 26 mg/ml (26,000 ppm) >240 min.
Carmustine 3.3 mg/ml (3,300 ppm) 47.5 min.
Cisplatin 1 mg/ml (1,000 ppm) >240 min.
Cyclophosphamide 20 mq/ml (20,000 ppm) >240 min.
Dacarbazine 10 mg/ml (10,000 ppm) >240 min.
Doxorubicin HCL 2 mq/ml (2,000 ppm) >240 min.
Eribulin Mesylate 0.5 mg/ml (500 ppm) >240 min.
Etoposide 20 mq/ml (20,000 ppm) >240 min.
Floxuridine 100 mg/ml (100,000 ppm) >240 min.
Fluorouracil 50 mq/ml (50,000 ppm) >240 min.
Ifosfamide 50 mq/ml (50,000 ppm) >240 min.
Lenvatinib 20 mg/ml (20,000 ppm) >240 min.
Mitoxantrone 2 mg/ml (2,000 ppm) >240 min.
Paclitaxel, 6 mg/ml (6,000 ppm) >240 min.
Pemetrexed 25 mg/ml (25,000 ppm) >240 min.
Sorafenib Tosylate 200 mg/ml (200,000 ppm) >240 min.
Tamoxifen 2 mg/ml (2,000 ppm) >240 min.
Thiotepa 10 mg/ml (10,000 ppm) 38.2 min.
Vinblastine Sulfate 1 mg/ml (1,000 ppm) >240 min.
Vincristine Sulfate 1 mg/ml (1,000 ppm) >240 min.
Vinorelbine 10 mg/ml (10,000 ppm) >240 min.
Fentanyl Citrate 100mcg/2mL >240 min.
Simulated Gastric Acid 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid >240 min.
Fentanyl in Gastric Acid 50/50 mix solution >240 min.
Caution: Carmustine and Thiotepa have low penetration times of 47.5 min. and 38.2 min. respectively
CHEMICAL CONCENTRATION XTRA
Cabazitaxel 60 mg/1.5ml (40,000 ppm) >240 min.
Capecitabine 26 mg/ml (26,000 ppm) >240 min.
Carmustine 3.3 mg/ml (3,300 ppm) 37.3 min.
Cisplatin 1 mg/ml (1,000 ppm) >240 min.
Cyclophosphamide 20 mq/ml (20,000 ppm) >240 min.
Dacarbazine 10 mg/ml (10,000 ppm) >240 min.
Doxorubicin HCL 2 mq/ml (2,000 ppm) >240 min.
Eribulin Mesylate 0.5 mg/ml (500 ppm) >240 min.
Etoposide 20 mq/ml (20,000 ppm) >240 min.
Floxuridine 100 mg/ml (100,000 ppm) >240 min.
Fluorouracil 50 mq/ml (50,000 ppm) >240 min.
Ifosfamide 50 mq/ml (50,000 ppm) >240 min.
Lenvatinib 20 mg/ml (20,000 ppm) >240 min.
Mitoxantrone 2 mg/ml (2,000 ppm) >240 min.
Paclitaxel, 6 mg/ml (6,000 ppm) >240 min.
Pemetrexed 25 mg/ml (25,000 ppm) >240 min.
Sorafenib Tosylate 200 mg/ml (200,000 ppm) >240 min.
Tamoxifen 2 mg/ml (2,000 ppm) >240 min.
Thiotepa 10 mg/ml (10,000 ppm) 30.1 min.
Vinblastine Sulfate 1 mg/ml (1,000 ppm) >240 min.
Vincristine Sulfate 1 mg/ml (1,000 ppm) >240 min.
Vinorelbine 10 mg/ml (10,000 ppm) >240 min.
Fentanyl Citrate 100mcg/2mL >240 min.
Simulated Gastric Acid 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid >240 min.
Fentanyl in Gastric Acid 50/50 mix solution >240 min.
Caution: Carmustine and Thiotepa have low penetration times of 37.3 min. and 30.1 min. respectively
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202416: Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202416
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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