510(k) · Cleared
ClearedNitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
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 May 22, 2025 as substantially equivalent to K231365 (Anhui Intco Medical Products Co., Ltd., 2024) after an 80-day review. Its family tree reaches back 3 generations to 2008.
- Decided
- May 22, 2025
- Review
- 80 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K082457 (2008). No later device cites it as a predicate yet.
- Root · 3 generations backK082457 Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination…Ansell Healthcare Products, Inc. · 2008
- 2 generations backK200671 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile…Ansell Healthcare Products, LLC · 2020
- 1 generation backK231365 Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored…Anhui Intco Medical Products Co., Ltd. · 2024
- This deviceK250630 Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for…Basic Medical Technology, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K082457 | Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination Gloves… | Ansell Healthcare Products, Inc. | 2008 | — |
| −2 | K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue… | Ansell Healthcare Products, LLC | 2020 | — |
| −1 | K231365 | Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and… | Anhui Intco Medical Products Co., Ltd. | 2024 | — |
| 0 (this device) | K250630 | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with… | 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 |
|---|---|---|---|
| * | K231365 | Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use…Summary page 6…: General Hospital Device Class: Class I 4. Predicate Device Information Primary Predicate Device: Applicant: Anhui Intco Medical Products Co., Ltd. 510(k) #: K231365 Trade Name: Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs… | 2024 |
| † | K243441 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl… | 2025 |
| † | K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With… | 2025 |
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 17 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 3 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?
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate 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, Gastric acid and Xylazine in accordance with ASTM D6978-05 standards…
Read the full statement (254 words)
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate 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, Gastric acid and Xylazine in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Chemotherapy Drugs Minimum Breakthrough Detection Time
Carboplatin, 10 mg/ml >240 min.
Carmustine, 3.3 mg/ml 11.6 min.
Cisplatin, 1 mg/ml >240 min.
Cyclophosphamide, 20 mg/ml >240 min.
Cytarabine HCI 100 mg/ml >240 min.
Dacarbazine, 10 mg/ml >240 min.
Daunorubicin HCL, 5 mg/ml >240 min.
Doxorubicin HCI, 2 mg/ml >240 min.
Etoposide, 20 mg/ml >240 min.
5-Fluorouracil, 50 mg/ml >240 min.
Gemcitabine HCI, 38 mg/ml >240 min.
Idarubicin HCI, 1 mg/ml >240 min.
Ifosfamide, 50 mg/ml >240 min.
Irinotecan HCI, 20 mg/ml >240 min.
Mechlorethamine HCI, 1 mg/ml >240 min.
Melphalan HCI, 5 mg/ml >240 min.
Methotrexate, 25 mg/ml >240 min.
Mitomycin-C, 0.5 mg/ml >240 min.
Mitoxantrone HCL,, 2 mg/ml >240 min.
Pacilitaxel, 6 mg/ml >240 min.
Thiotepa, 10 mg/ml 25.3 min.
Vincrinstine Sulfate,1 mg/ml >240 min.
Fentanyl, Gastric Acid and Xylazine Minimum Breakthrough Detection Time
Fentanyl Citrate Injection, S0mcg/ml >240 min.
Simulated Gastric Acid >240 min.
Fentanyl Citrate (50mcg/ml): Xylazine HCI(100mg/ml), 50:50 >240 min.
*Please note that the following drugs have extremely low permeation times:
Carmustine: 11.6 minutes, Thiotepa:25.3 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/K250630 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250630: Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250630
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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