510(k) · Cleared
ClearedBiodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Better Care Plastic Technology Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Oct 11, 2023 as substantially equivalent to K223437 (Hartalega NGC Sdn. Bhd., 2023) after a 91-day review. Its family tree reaches back 2 generations to 2020.
- Decided
- Oct 11, 2023
- Review
- 91 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K200581 (2020). No later device cites it as a predicate yet.
- Root · 2 generations backK200581 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use…Hartalega NGC Sdn. Bhd. · 2020
- 1 generation backK223437 Biodegradable Nitrile Powder Free Examination Glove Tested for Use…Hartalega NGC Sdn. Bhd. · 2023
- This deviceK232070 Biodegradable Nitrile Examination Gloves Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with… | Hartalega NGC Sdn. Bhd. | 2020 | — |
| −1 | K223437 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use with… | Hartalega NGC Sdn. Bhd. | 2023 | — |
| 0 (this device) | K232070 | Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K223437 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy…Summary page 6…ice Information: Hartalega NGC SDN. BHD. Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) (K223437) 4. Device Description: Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (B… | 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 3 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 2 ancestors has a recall.
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?
The glove 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 Citrate using ASTM D6978-05(2019). Black Glove: Chemotherapy Drug Minimum Breakthrough Detection Time in Minutes Carmustine 3.3 mg/ml {3,300 ppm) 23.0 Cisplatin 1mg/ml {1,000 ppm) >240 Cyclophosphamide 20mg/ml (20,000 ppm) >240…
Read the full statement (239 words)
The glove 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 Citrate using ASTM D6978-05(2019).
Black Glove:
Chemotherapy Drug Minimum Breakthrough Detection Time in Minutes
Carmustine 3.3 mg/ml {3,300 ppm) 23.0
Cisplatin 1mg/ml {1,000 ppm) >240
Cyclophosphamide 20mg/ml (20,000 ppm) >240
Dacarbazine 10 mg/ml (10,000 ppm) >240
Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240
Etoposide, 20 mg/ml (20,000 ppm) >240
Fluorouracil, 50mg/ml (50,000ppm) >240
Methotrexate, 25mg/ml (25,000ppm) >240
Paclitaxel, 6mg/ml {6,000ppm) >240
Thiotepa, 10mg/ml (10,000ppm) 45.9
Fentanyl Citrate Minimum Breakthrough Detection Time in Minutes
Fentanyl Citrate Injection, 100mcg/2mg >240
*Please note that the following drugs have extremely low permeation times: Carmustine: 23.0 minutes, Thie Tepa: 45.9 minutes
Warning: Do not use with Carmustine and Thiotepa.
Green Glove:
Chemotherapy Drug Minimum Breakthrough Detection Time in Minutes
Carmustine 3.3 mg/ml {3,300 ppm) 15.4
Cisplatin 1mg/ml {1,000 ppm) >240
Cyclophosphamide 20mg/ml (20,000 ppm) >240
Dacarbazine 10 mg/ml (10,000 ppm) >240
Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240
Etoposide, 20 mg/ml (20,000 ppm) >240
Fluorouracil, 50mg/ml (50,000ppm) >240
Methotrexate, 25mg/ml (25,000ppm) >240
Paclitaxel, 6mg/ml {6,000ppm) >240
Thiotepa, 10mg/ml (10,000ppm) 34.4
Fentanyl Citrate Minimum Breakthrough Detection Time in Minutes
Fentanyl Citrate Injection, 100mcg/2mg >240
*Please note that the following drugs have extremely low permeation times: Carmustine: 15.4 minutes, Thio Tepa: 34.4 minutes
Warning: Do not use with Carmustine and Thiotepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232070: Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232070
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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