510(k) · Cleared
ClearedPowder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. 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
Better Care Plastic Technology Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Mar 18, 2025 as substantially equivalent to K232266 (Better Care Plastic Technology Co., Ltd., 2023) after a 204-day review. Its family tree reaches back 4 generations to 2019.
- Decided
- Mar 18, 2025
- Review
- 204 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K183287 (2019). No later device cites it as a predicate yet.
- Root · 4 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 3 generations backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- 2 generations backK221269 Powder Free Nitrile Examination Gloves (Blue),Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2022
- 1 generation backK232266 Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non…Better Care Plastic Technology Co., Ltd. · 2023
- This deviceK242533 Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non…Better Care Plastic Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −3 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| −2 | K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2022 | — |
| −1 | K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile… | Better Care Plastic Technology Co., Ltd. | 2023 | — |
| 0 (this device) | K242533 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low… | Better Care Plastic Technology Co., Ltd. | 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 |
|---|---|---|---|
| * | K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for…Summary page 6…re Plastic Technology Co., Ltd. Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232266) 4. Device Description: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. T… | 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 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K232266.
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?
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. Chemotherapy Drug and Concentration Bleomycin Sulfate 15mg/ml (15000 ppm) Busulfan 6mg/ml (6,000 ppm) Carboplatin 10mg/ml (10,000 ppm) Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) Cisplatin 1mg/ml (1,000 ppm)…
Read the full statement (278 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.
Chemotherapy Drug and Concentration
Bleomycin Sulfate 15mg/ml (15000 ppm)
Busulfan 6mg/ml (6,000 ppm)
Carboplatin 10mg/ml (10,000 ppm)
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm)
Cisplatin 1mg/ml (1,000 ppm)
Cyclophosphamide 20mg/ml (20,000 ppm)
Cytarabine HCL, 100 mg/ml (100,000 ppm)
Dacarbazine 10 mg/ml (10,000 ppm)
Daunorubicin HCL, 5 mg/ml (5,000 ppm)
Docetaxel, 10 mg/ml (10,000 ppm)
Doxorubicin HCL, 2 mg/ml (2,000 ppm)
Epirubicin HCL, 2 mg/ml (2,000 ppm)
Etoposide, 20 mg/ml (20,000 ppm)
Fludarabine, 25 mg/ml (25,000 ppm)
Fluorouracil, 50mg/ml (50,000ppm)
Gemcitabine, 38mg/ml (38,000ppm)
Idarubicin HCL, Img/ml (1,000ppm)
Ifosfamide, 50mg/ml (50,000ppm)
Irinotecan, 20mg/ml (20,000ppm)
Mechlorethamine HCI, Img/ml (1,000ppm)
Melphalan, Smg/ml (5,000ppm)
Methotrexate, 25mg/ml (25,000ppm)
Mitomycin C, 0.5mg/ml (500ppm)
Mitoxantrone HCL, 2mg/ml (2,000ppm)
Oxaliplatin, Smg/ml (5,000ppm)
Paclitaxel, 6mg/ml (6,000ppm)
Paraplatin, 10mg/ml (10,000ppm)
Rituximab, 10mg/ml (10,000ppm)
Thiotepa, 10mg/ml (10,000ppm)
Topotecan, 1mg/ml (1,000ppm)
Trisenox, 1mg/ml (1,000ppm)
Velcade, Img/ml (1,000ppm)
Vincristine Sulfate, 1mg/ml (1,000ppm)
Fentanyl Citrate & other drugs
Fentanyl Citrate Injection, 100mcg/2mg
Chloroquine 50mg/ml (50,000ppm)
Cyclosporin A 100 mg/ml (100,000 ppm)
Minimum Breakthrough Detection Time (BDT) in Minutes
>240
>240
>240
22.8, Do not use
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
>240
46.9, Do not use
>240
>240
>240
>240
Minimum Breakthrough Detection Time in Minutes
>240
>240
>240
Retrovir, 10mg/ml (10,000ppm) >240
Please note that the following drugs have extremely low permeation times:
Carmustine: 22.8 minutes, Thiotepa: 46.9 minutes
*Warning: Do not use with Carmustine and Thiotepa.
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/K242533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242533: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. 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/K242533
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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