510(k) · Cleared
ClearedNitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gmp Medicare Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Apr 23, 2025 after a 26-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 23, 2025
- Review
- 26 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?
An examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs with Gastric Acid, Xylazine and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. No Chemotherapy Drugs Concentration (mg/ml)…
Read the full statement (425 words)
An examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs with Gastric Acid, Xylazine and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
No Chemotherapy Drugs Concentration (mg/ml) Minimum Breakthrough Detection Time (Min.)
1 Amethopterin 25.0 >240
2 Azacitidine (Vidaza) 25.0 >240
3 Bendamustine HCI 5.0 >240
4 Bleomycin Sulfate 15.0 >240
5 Busulfan 6.0 >240
6 Capecitabine 26.0 >240
7 Carboplatin 10.0 >240
8 Carfilzomib 2.0 >240
9 Carmustine 33 11.0
10 Cetuximab (Erbitux) 2.0 >240
11 Chlroquine 50.0 >240
12 Cisplatin 1.0 >240
13 Cladribine 1.0 >240
14 Cyclophosphamide 20.0 >240
15 Cyclosporin A 100.0 >240
16 Cytarabine 100.0 >240
17 Cytovene 10.0 >240
18 Dacarbazine 10.0 >240
19 Dactinomycin 0.5 >240
20 Daunorubin HCI 5.0 >240
21 Decitabine 5.0 >240
22 Docetaxel 10.0 >240
23 Doxorubicin Hydrochloride 2.0 >240
24 Ellence 2.0 >240
25 Eribulin Mesylate 0.5 >240
26 Etoposide 20.0 >240
27 Fludarabine 25.0 >240
28 Fluorouracil 50.0 >240
29 Fulvestrant 50.0 >240
30 Gemcitabine 38.0 >240
31 Idarubicin 1.0 >240
32 lfostamide 00.0 >240
33 Irinotecan 20.0 >240
34 Ixabepilone 2.0 >240
35 Leuprolide Acetate 5.0 >240
36 Mechlorethamine 1.0 >240
37 Melphalan 5.0 >240
38 MESNA 100.0 >240
39 Methotrexate 25.0 >240
40 Mitomycin C 0.5 >240
41 Mitoxantrone 2.0 >240
42 Oxaliplatin 5.0 >240
43 Paclitaxel 6.0 >240
44 Pemetrexed 250 >240
45 Pertuzumab 30.0 >240
46 Propofol 10.0 >240
47 Raltitrexed 0.5 >240
48 Retrovir 10.0 >240
49 Rituximab 10.0 >240
50 Temsirolimus 25.0 >240
51 Thiotepa 10.0 39.0
52 Topotecan 1.0 >240
53 Trastuzumab 21.0 >240
54 Triclosan 1.0 >240
55 Trisenox 1.0 >240
56 Velcade (Bortezomib) 1.0 >240
57 Vincristine Sulfate 1.0 >240
58 Vinblastine Sulfate 1.0 >240
59 Vinorelbine 10.0 >240
60 Zoledronic Acid 0.8 >240
Please note that Carmustine and Thiotepa have extremely low permeation times of 11 minutes and 39 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa
no breakthrough detected up to 240 minutes.
to have no breakthrough detected up to 240 minutes.
found to have no breakthrough detected up to 240 minutes.
Gastric Acid - Under the testing conditions of ASTM D6978-05, Simulated Gastric Acid was found to have
Xylazine - Under the testing conditions of ASTM D6978-05, Xylazine HCI Injection (100 mg/ml) was found
Fentanyl - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2ml) was
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/K250944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250944: Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250944
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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