510(k) · Cleared
ClearedNitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Basic Medical Technology, Inc. · LZA Polymer Patient Examination Glove
Cleared on Feb 18, 2025 as substantially equivalent to K230779 (Shanxi Hongjin Plastic Technology Co., Ltd., 2023) after a 70-day review. Its family tree reaches back 3 generations to 2019.
- Decided
- Feb 18, 2025
- Review
- 70 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K183287 (2019). No later device cites it as a predicate yet.
- Root · 3 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 2 generations backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- 1 generation backK230779 Powder Free Nitrile Examination Gloves (Black), Tested for Use with…Shanxi Hongjin Plastic Technology Co., Ltd. · 2023
- This deviceK243792 Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…Basic Medical Technology, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −2 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| −1 | K230779 | Powder Free Nitrile Examination Gloves (Black), Tested for Use with… | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023 | — |
| 0 (this device) | K243792 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid… | Basic Medical Technology, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K230779 | Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs…Summary page 6…formation Shanxi Hongjin Plastic Technology Co., Ltd. Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K230779) Product code: LZA, LZC, QDO, OPJ. 5. Device Description: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Dr… | 2023 |
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 6 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K230779.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black) is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. Gloves have been tested for use with Chemotherapy drugs and Fentanyl using ASTM D6978-05. Chemotherapy Drugs Minimum Breakthrough Detection Time Carmustine (3.3mg/ml) 14.2 min Cisplatin (1mg/ml) >240 min…
Read the full statement (264 words)
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black) is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner.
Gloves have been tested for use with Chemotherapy drugs and Fentanyl using ASTM D6978-05.
Chemotherapy Drugs Minimum Breakthrough Detection Time
Carmustine (3.3mg/ml) 14.2 min
Cisplatin (1mg/ml) >240 min
Cyclophosphamide (20mg/ml) >240 min
Dacarbazine (10.0 mg/ml) >240 min
Doxorubicin HCI (2 mg/ml) >240 min
Etoposide (20mg/ml) >240 min
Fluorouracil (50mg/ml) >240 min
Paclitaxel (6mg/ml) >240 min
Thiotepa (10mg/ml) 14.7 min
Fentanyl Concentration Minimum Breakthrough Detection Time
Fentanyl Citrate Injection, 100mcg/2ml >240 min
*Please note that the following drugs have extremely low permeation times:
Carmustine: 14.2 minutes, Thiotepa:14.7 minutes
Warning: Do not use with Carmustine and Thiotepa.
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (White) is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner.
Gloves have been tested for use with Chemotherapy drugs and Fentanyl using ASTM D6978-05.
Chem Drug Concentration Minimum Breakthrough Detection Time
Carmustine (3.3mg/ml) 16.7 min
Cisplatin (1mg/ml) >240 min
Cyclophosphamide (20mg/ml) >240 min
Dacarbazine (10.0 mg/ml) >240 min
Doxorubicin HCI (2 mg/ml) >240 min
Etoposide (20mg/ml) >240 min
Fluorouracil (50mg/ml) >240 min
Paclitaxel (6mg/ml) >240 min
Thiotepa (10mg/ml) 16.2 min
Fentanyl Concentration Minimum Breakthrough Detection Time
Fentanyl Citrate Injection, 100mcg/2ml >240 min
*Please note that the following drugs have extremely low permeation times:
Carmustine: 16.7 minutes, Thiotepa:16.2 minutes
Warning: Do not use with Carmustine and Thio Tepa.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243792: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243792
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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