510(k) · Cleared
ClearedNitrile Powder-Free Exam Gloves 2.8, 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 Jul 9, 2025 after a 167-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 9, 2025
- Review
- 167 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 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 1 Bendamustine HCI, 5 mg/ml 2 Bortezomib (Velcade), 1 mg/ml 3…
Read the full statement (482 words)
The glove is 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
1 Bendamustine HCI, 5 mg/ml
2 Bortezomib (Velcade), 1 mg/ml
3 Busulfan, 6 mg/ml
4 Carboplatin, 10 mg/ml
5 Carmustine, 3.3 mg/ml
6 Carfilzomib, 2 mg/ml
7 Cetuximab (Erbitux), 2 mg/ml
8 Chloroquine, 50mg/ml
9 Cisplatin, 1 mg/ml
10 Cladribine, 1.0 mg/ml
11 Cyclophosphamide, 20 mg/ml
12 Cyclosporin A,100mg/ml
13 Cytarabine HCI, 100 mg/ml
14 Cytovene, 10 mg/ml
15 Dacarbazine, 10 mg/ml
16 Daunorubicin HCI, 5 mg/ml
17 Decitabine, 5 mg/ml
18 Docetaxel, 10 mg/ml
19 Doxorubicin HCI, 2 mg/ml
20 Epirubicin HCI, 2 mg/ml
21 Etoposide, 20 mg/ml
22 Fludarabine Phosphate, 25 mg/ml
23 5-Fluorouracil, 50 mg/ml
24 Gemcitabine HCI, 38 mg/ml
25 Idarubicin HCI, 1 mg/ml
26 Ifosfamide, 50 mg/ml
27 Irinotecan HCI, 20 mg/ml
28 Mechlorethamine HCI, 1 mg/ml
29 Melphalan HCI, 5 mg/ml
31 Methotrexate, 25 mg/ml
30 Mitomycin-C, 0.5 mg/ml
32 Mitoxantrone HCI, 2 mg/ml
33 Oxaliplatin, 2 mg/ml
34 Pacilitaxel, 6 mg/ml
35 Retrovir, 10 mg/ml
36 ThioTEPA, 10 mg/ml
37 Trisonex, 1 mg/ml
38 Vidaza(Azacitidine),25 mg/ml
39 Vincristine Sulfate,1 mg/ml
Fentanyl, Gastric Acid and Xylazine
1 Fentanyl Citrate Injection,50mcg/ml
2 Gastric Acid
3 Fentanyl Citrate: Xylazine HCL, 50:50
*Please note that the following drugs have extremely low permeation times:
Carmustine: 12.6 minutes, Thio Tepa:27.1 minutes
Warning: Do not use with Carmustine and Thiotepa.
Dark Blue Glove:
Chemotherapy Drugs
1 Bendamustine HCI, 5 mg/ml
2 Bortezomib (Velcade), 1 mg/ml
3 Busulfan, 6 mg/ml
4 Carboplatin, 10 mg/ml
5 Carmustine, 3.3 mg/ml
6 Carfilzomib, 2 mg/ml
7 Cetuximab (Erbitux), 2 mg/ml
8 Chloroquine, 50mg/ml
9 Cisplatin, 1 mg/ml
10 Cladribine, 1.0 mg/ml
11 Cyclophosphamide, 20 mg/ml
12 Cyclosporin A,100mg/ml
13 Cytarabine HCI, 100 mg/ml
14 Cytovene, 10 mg/ml
15 Dacarbazine, 10 mg/ml
16 Daunorubicin HCI, 5 mg/ml
17 Decitabine, 5 mg/ml
18 Docetaxel, 10 mg/ml
19 Doxorubicin HCI, 2 mg/ml
20 Epirubicin HCI, 2 mg/ml
21 Etoposide, 20 mg/ml
22 Fludarabine Phosphate, 25 mg/ml
23 5-Fluorouracil, 50 mg/ml
24 Gemcitabine HCI, 38 mg/ml
25 Idarubicin HCI, 1 mg/ml
26 Ifosfamide, 50 mg/ml
27 Irinotecan HCI, 20 mg/ml
28 Mechlorethamine HCI, 1 mg/ml
29 Melphalan HCI, 5 mg/ml
31 Methotrexate, 25 mg/ml
30 Mitomycin-C, 0.5 mg/ml
32 Mitoxantrone HCI, 2 mg/ml
33 Oxaliplatin, 2 mg/ml
34 Pacilitaxel, 6 mg/ml
35 Retrovir, 10 mg/ml
36 ThioTEPA, 10 mg/ml
37 Trisonex, 1 mg/ml
38 Vidaza(Azacitidine),25 mg/ml
39 Vincristine Sulfate,1 mg/ml
Fentanyl, Gastric Acid and Xylazine
1 Fentanyl Citrate Injection,50mcg/ml
2 Gastric Acid
3 Fentanyl Citrate: Xylazine HCL, 50:50
*Please note that the following drugs have extremely low permeation times:
Carmustine: 11.0 minutes, Thio Tepa:26.0 minutes
Warning: Do not use with Carmustine and Thiotepa.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250193 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250193: Nitrile Powder-Free Exam Gloves 2.8, 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 4, 2026. https://510kreport.com/device/K250193
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026