510(k) · Cleared
ClearedDisposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Global (Vietnam) Enterprise Corporation · LZA Polymer Patient Examination Glove
Cleared on Aug 21, 2025 as substantially equivalent to K244034 (Ever Global (Vietnam) Enterprise Corporation, 2025) after a 34-day review. Its family tree reaches back 8 generations to 2004.
- Decided
- Aug 21, 2025
- Review
- 34 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K042805 (2004). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 7 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 6 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 5 generations backK161422 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2016
- 4 generations backK171171 KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile…Koon Seng Sdn Bhd · 2018
- 3 generations backK190403 Disposable Powder Free Nitrile Examination Glove, White, Tested for…Ever Global (Vietnam) Enterprise Corporation · 2019
- 2 generations backK193555 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested…Ever Global (Vietnam) Enterprise Corp · 2020
- 1 generation backK244034 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested…Ever Global (Vietnam) Enterprise Corporation · 2025
- This deviceK252244 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested…Ever Global (Vietnam) Enterprise Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −7 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −6 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −5 | K161422 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2016 | — |
| −4 | K171171 | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for… | Koon Seng Sdn Bhd | 2018 | — |
| −3 | K190403 | Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With… | Ever Global (Vietnam) Enterprise Corporation | 2019 | — |
| −2 | K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use… | Ever Global (Vietnam) Enterprise Corp | 2020 | — |
| −1 | K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use… | Ever Global (Vietnam) Enterprise Corporation | 2025 | — |
| 0 (this device) | K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use… | Ever Global (Vietnam) Enterprise Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
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 |
|---|---|---|---|
| * | K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…Summary page 6…Fentanyl Citrate And Xylazine Company name: Ever Global (Vietnam) Enterprise Corporation 510(K) Number: K244034 ______________________________________________________________________________________ Premarket Notification 510(k) Disposable… | 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 21 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 9 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?
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner’s hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with cchemotherapy drugs, fentanyl citrate, xylazine, gastric acid, fentanyl in gastric acid and xylazine in gastric acid in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to…
Read the full statement (472 words)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner’s hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with cchemotherapy drugs, fentanyl citrate, xylazine, gastric acid, fentanyl in gastric acid and xylazine in gastric acid in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.
Tested Chemotherapy and Concentration(mg/ml) Minimum Breakthrough Detection Time(Min)
Other Liquid Hazardous Drug
01 Arsenic Trioxide 1.0 > 240
02 Azacitidine (Vidaza) 25.0 > 240
03 Bendamustine HCl 5.0 > 240
04 Bleomycin Sulfate 15.0 > 240
05 Bortezomib (Velcade) 1.0 > 240
06 Busulfan 6.0 > 240
07 Carboplatin 10.0 > 240
08 Carfilzomib 2.0 > 240
09 Carmustine (BCNU) 3.3 21.5
10 Cetuximab (Erbitux) 2.0 > 240
11 Chloroquine 50.0 > 240
12 Cisplatin 1.0 > 240
13 Cladribine 1.0 > 240
14 Cyclophosphamide 20.0 > 240
15 Cyclosporine A 100.0 > 240
16 Cytarabine 100.0 > 240
17 Cytovene (Ganciclovir) 10.0 > 240
18 Dacarbazine 10.0 > 240
19 Daunorubicin 5.0 > 240
20 Decitabine 5.0 > 240
21 Docetaxel 10.0 > 240
22 Doxorubicin Hydrochloride 2.0 > 240
23 Epirubicin (Ellence) 2.0 > 240
24 Etoposide 20.0 > 240
25 Fludarabine 25.0 > 240
26 Fluorouracil 50.0 > 240
27 Fulvestrant 50.0 > 240
28 Gemcitabine 38.0 > 240
29 Idarubicin 1.0 > 240
30 Ifosfamide 50.0 > 240
31 Irinotecan 20.0 > 240
32 Mechlorethamine HCl 1.0 > 240
33 Melphalan 5.0 > 240
34 Methotrexate 25.0 > 240
35 Mesna 100.0 > 240
36 Mitomycin C 0.5 > 240
37 Mitoxantrone 2.0 > 240
38 Oxaliplatin 5.0 > 240
39 Paclitaxel 6.0 > 240
40 Paraplatin 10.0 > 240
41 Pemetrexed 25.0 > 240
42 Pertuzumab 30.0 > 240
43 Raltitrexed 0.5 > 240
44 Retrovir 10.0 > 240
45 Rituximab 10.0 > 240
46 Temsirolimus 25.0 > 240
47 Thiotepa 10.0 13.6
48 Topotecan HCl 1.0 > 240
49 Trastuzumab 21.0 > 240
50 Triclosan 2.0 > 240
51 Trisenox 1.0 > 240
52 Vinblastine 1.0 > 240
53 Vincristine Sulfate 1.0 > 240
54 Vinorelbine 10.0 > 240
55 Zoledronic Acid 0.8 > 240
56 Fentanyl Citrate 100.0 mcg/ 2.0 ml > 240
57 Xylazine HCl 100.0 > 240
58 Fentanyl Citrate Injection/ 100.0 mcg/ 2.0 ml > 240
Simulated Gastric Acid Fluid
Mix 50/50 Solution
59 Simulated Gastric Acid Fluid/ 100.0 > 240
Xylazine HCl Mix 50/50 Solution
Warning: do not use with Carmustine and Thiotepa.
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low
permeation time:
Carmustine (BCNU) 3.3 mg/ml 21.5 minutes
Thiotepa 10.0 mg/ml 13.6 minutes
Tested Non-drugs Solution Concentration(mg/ml) Minimum Breakthrough Detection Time(Min)
01 Simulated Gastric Acid Fluid - > 240
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/K252244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252244: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252244
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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