510(k) · Cleared
ClearedNitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)
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 Jan 31, 2025 as substantially equivalent to K240051 (Lingshi Hongruida Health Protection Technology Co., Ltd., 2024) after an 86-day review. Its family tree reaches back 2 generations to 2022.
- Decided
- Jan 31, 2025
- Review
- 86 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K223320 (2022). No later device cites it as a predicate yet.
- Root · 2 generations backK223320 Powder Free Nitrile Examination Gloves (Blue), Tested for Use with…Lingshi Hongruida Health Protection Technology Co., Ltd. · 2022
- 1 generation backK240051 Powder Free Nitrile Examination Gloves (Blue), Tested For Use With…Lingshi Hongruida Health Protection Technology Co., Ltd. · 2024
- This deviceK243441 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 |
|---|---|---|---|---|---|
| −2 | K223320 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2022 | — |
| −1 | K240051 | Powder Free Nitrile Examination Gloves (Blue), Tested For Use With… | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2024 | — |
| 0 (this device) | K243441 | 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 |
|---|---|---|---|
| * | K240051 | Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs…Summary page 7…alth Protection Technology Co., Ltd. Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs (K240051) Product code: LZA, LZC, QDO, OPJ. 5. Device Description: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy D… | 2024 |
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 1.3 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. 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 were tested for use with Chemotherapy drugs, Fentanyl and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs. Light Blue glove: Chemotherapy Drugs Bendamustine HCI, 5 mg/ml Bortezomib, 1 mg/m Busulfan, 6 mg/mi…
Read the full statement (393 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 were tested for use with Chemotherapy drugs, Fentanyl and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Light Blue glove:
Chemotherapy Drugs
Bendamustine HCI, 5 mg/ml
Bortezomib, 1 mg/m
Busulfan, 6 mg/mi
Carboplatin, 10 mg/ml
Carmustine, 3.3 mg/ml
Carfilzomib, 2 mg/mi
Cetuximab (Erbitux) 2 mg/ml
Chloroquine, 50mg/ml
Cisplatin, 1 mg/ml
Cladribine, 1.0 mg/ml
Cyclophosphamide, 20 mg/m
Cyclosporin A,100mg/ml
Cytarabine HCI, 100 mg/ml
Cytovene, 10 mg/mi
Dacarbazine, 10 mg/ml
Daunorubicin HCI, 5 mg/mi
Decitabine, 5 mg/ml
Docetaxel, 10 mg/ml
Doxorubicin HCI, 2 mg/ml
Epirubicin HCI, 2 mg/mi
Etoposide, 20 mg/ml
Fludarabine, 25 mg/mi
Fluorouracil, 50 mg/mi
Gemcitabine HCI,, 38 mg/mi
Idarubicin HCI,, 1 mg/ml
Ifosfamide, 50 mg/ml
Irinotecan, 20 mg/mi
Mechlorethamine HCI, 1 mg/mli
Melphalan HCI, 5 mg/mi
Methotrexate, 25 mg/ml
Mitomycin-C, 0.5 mg/mi
Mitoxantrone HCI, 2 mg/ml
Oxaliplatin, 2 mg/ml
Paclitaxel, 6 mg/m
Retrovir, 10 mg/ml
ThioTEPA, 10 mg/mi
Trisenox, 1 mg/ml
Vidaza (Azacitidine),25 mg/ml
Vincristine Sulfate,1 mg/mi
Fentanyl Citrate and Gastric Acid
Fentanyl Citrate Injection, 100mcg/2ml
Simulated Gastric Acid
*Please note that the following drugs have extremely low permeation times:
Carmustine: 16.6 minutes, Thio Tepa: 44.9 minutes
Warning: Do not use with Carmustine and Thio Tepa.
Dark Blue glove:
Chemotherapy Drugs
Bendamustine HCI, 5 mg/mi
Bortezomib, 1 mg/mi
Busulfan, 6 mg/ml
Carboplatin, 10 mg/ml
Carmustine, 3.3 mg/ml
Carfilzomib, 2 mg/mi
Cetuximab (Erbitux) 2 mg/ml
Chloroquine, 50mg/ml
Cisplatin, 1 mg/ml
Cladribine, 1.0 mg/ml
Cyclophosphamide, 20 mg/mi
Cyclosporin A,100mg/ml
Cytarabine HCI, 100 mg/ml
Cytovene, 10 mg/ml
Dacarbazine, 10 mg/ml
Daunorubicin HCI, 5 mg/mi
Decitabine, 5 mg/ml
Docetaxel, 10 mg/ml
Doxorubicin HCI, 2 mg/ml
Epirubicin HCI, 2 mg/mi
Etoposide, 20 mg/ml
Fludarabine, 25 mg/mi
Fluorouracil, 50 mg/mi
Gemcitabine HCI,, 38 mg/mi
Idarubicin HCI,, 1 mg/ml
Ifosfamide, 50 mg/ml
Irinotecan, 20 mg/mi
Mechlorethamine HCI, 1 mg/mi
Melphalan HCI, 5 mg/ml
Methotrexate, 25 mg/mi
Mitomycin-C, 0.5 mg/ml
Mitoxantrone HCI, 2 mg/ml
Oxaliplatin, 2 mg/ml
Paclitaxel, 6 mg/mi
Retrovir, 10 mg/ml
ThioTEPA, 10 mg/ml
Trisenox, 1 mg/ml
Vidaza (Azacitidine),25 mg/ml
Vincristine Sulfate,1 mg/mi
Fentanyl Citrate and Gastric Acid
Fentanyl Citrate Injection, 100mcg/2ml
Simulated Gastric Acid
*Please note that the following drugs have extremely low permeation times:
Carmustine: 21.5 minutes, Thio Tepa: 17.9 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/K243441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243441: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243441
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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