510(k) · Cleared
ClearedBiodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntex Healthcare Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Sep 8, 2023 as substantially equivalent to K200581 (Hartalega NGC Sdn. Bhd., 2020) after a 95-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Sep 8, 2023
- Review
- 95 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K200581 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backK200581 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use…Hartalega NGC Sdn. Bhd. · 2020
- This deviceK231643 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use…Syntex Healthcare Products Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with… | Hartalega NGC Sdn. Bhd. | 2020 | — |
| 0 (this device) | K231643 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with… | Syntex Healthcare Products 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 |
|---|---|---|---|
| * | K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…Summary page 5…ary Predicate Device: Hartalega NGC SDN. BHD. Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K200581) Reference Device: Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Examination Gloves (Blue) Tested for Use with… | 2020 |
| † | K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and… | 2022 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K200581.
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) Chemotherapy Drug Minimum BDT (Minutes) Azacytidine (Vidaza) 25 mg/ml (25000ppm) >240 Bleomycin Sulfate 15mg/ml (15000 ppm) >240 Busulfan 6mg/ml (6,000 ppm) >240 Carboplatin 10mg/ml (10,000 ppm) >240…
Read the full statement (276 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)
Chemotherapy Drug Minimum BDT (Minutes)
Azacytidine (Vidaza) 25 mg/ml (25000ppm) >240
Bleomycin Sulfate 15mg/ml (15000 ppm) >240
Busulfan 6mg/ml (6,000 ppm) >240
Carboplatin 10mg/ml (10,000 ppm) >240
Carmustine (BCNU)3.3 mg/ml (3,300 ppm) 12.9
Chloroquine 50mg/ml (50,000ppm) >240
Cisplatin 1mg/ml (1,000 ppm) >240
Cyclophosphamide 20mg/ml (20,000 ppm) >240
Cyclosporin A 100 mg/ml (100,000 ppm) >240
Cytarabine HCL, 100 mg/ml (100,000 ppm) >240
Dacarbazine 10 mg/ml (10,000 ppm) >240
Daunorubicin HCL, 5 mg/ml (5,000 ppm) >240
Docetaxel, 10 mg/ml (10,000 ppm) >240
Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240
Etoposide, 20 mg/ml (20,000 ppm) >240
Epirubicin HCL, 2 mg/ml (2,000 ppm) >240
Fludarabine, 25 mg/ml (25,000 ppm) >240
Fluorouracil, 50mg/ml (50,000ppm) >240
Gemcitabine, 38mg/ml (38,000ppm) >240
Idarubicin HCL, Img/ml (1,000ppm) >240
Ifosfamide, 50mg/ml (50,000ppm) >240
Irinotecan, 20mg/ml (20,000ppm) >240
Mechlorethamine HCI, 1mg/ml (1,000ppm) >240
Melphalan, Smg/ml (5,000ppm) >240
Methotrexate, 25mg/ml (25,000ppm) >240
Mitomycin C, 0.5mg/ml (500ppm) >240
Mitoxantrone HCL, 2mg/ml (2,000ppm) >240
Oxaliplatin, Smg/ml (5,000ppm) >240
Paclitaxel, 6mg/ml (6,000ppm) >240
Paraplatin, 10mg/ml (10,000ppm) >240
Retrovir, 10mg/ml (10,000ppm) >240
Rituximab, 10mg/ml (10,000ppm) >240
Thio Tepa, 10mg/ml (10,000ppm) 35.6
Topotecan, 1mg/ml (1,000ppm) >240
Trisenox, 1mg/ml (1,000ppm) >240
Velcade (Bortezomib), 1mg/ml (1,000ppm) >240
Vincristine Sulfate (Oncovin), 1mg/ml (1,000ppm) >240
Vinorelbine, 10 mg/ml (10000ppm) >240
Fentanyl Citrate Minimum BD'T Minutes
Fentanyl Citrate Injection (100 mcg/2ml) >240
*Please note that the following drugs have extremely low permeation times:
Carmustine: 12.9 minutes, Thio Tepa: 35.6 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/K231643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231643: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231643
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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