510(k) · Cleared
ClearedDisposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Growth (Vietnam) Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Dec 23, 2019 as substantially equivalent to K173942 (Central Medicare Sdn Bhd, 2018) after a 277-day review. Its family tree reaches back 6 generations to 2004. 2 later devices descend from it.
- Decided
- Dec 23, 2019
- Review
- 277 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K042805 (2004). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 5 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 4 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 3 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 2 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- 1 generation backK173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2018
- This deviceK190736 Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested…Ever Growth (Vietnam) Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK234097 Disposable Powder Free Nitrile Examination Glove, Natural Blue…Ever Growth (Vietnam) Corporation Limited · 2024
- Descendant · cites it directly · 0 of its ownK212036 Nitrile Powder Free Examination Gloves,Tested For Use With…Jiangsu Yanfang Medical Technology Co., Ltd. · 2021
Most influential descendants
Showing 2 of 2 · See all- K234097Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use…Ever Growth (Vietnam) Corporation Limited · 2024 · cites it directly0descendants
- K212036Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy DrugsJiangsu Yanfang Medical Technology Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −5 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −4 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −3 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −2 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| −1 | K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2018 | — |
| 0 (this device) | K190736 | Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use… | Ever Growth (Vietnam) Co., Ltd. | 2019 | — |
| +1 | K234097 | Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested… | Ever Growth (Vietnam) Corporation Limited | 2024 | — |
| +1 | K212036 | Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs | Jiangsu Yanfang Medical Technology Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy…Summary page 5…ested For Use With Chemotherapy Drugs Company name: Central Medicare Sdn. Bhd 510(K) Number: K173942 5.0 Device Description: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy D… | 2018 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K234097 (Ever Growth (Vietnam) Corporation Limited, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K173942.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. Test Chemotherapy Drug 01 Bleomycin Sulfate 02 Busulfan 03 Carboplatin 04 Carmustine…
Read the full statement (255 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 chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Test Chemotherapy Drug
01 Bleomycin Sulfate
02 Busulfan
03 Carboplatin
04 Carmustine (BCNU)
05 Chloroquine
06 Cisplatin
07 Cyclophosphamide
08 Cyclosporin A
09 Cytarabine
10 Dacarbazine (DTIC)
11 Daunorubicin
12 Docetaxel
13 Doxorubicin Hydrochloride
14 Epirubicin
15 Etoposide (Toposar)
16 Fludarabine
17 Fluorouracil
18 Gemcitabine
19 Idaribicin
20 Ifosfamide
21 Irinotecan
22 Mechlorethamine HCI
23 Melphalan
24 Methotrexate
25 Mitomycin C
26 Mitoxantrone
27 Oxaliplatin
28 Paclitaxel (Taxol)
29 Paraplatin
30 Retrovir
31 Rituximab
32 Thiotepa
33 Topotecan HCI
34 Trisonex
35 Velcade (Bortezomib)
36 Vincristine
Concentration(mg/ml)
15.0
6.0
10.0
33
50.0
1.0
20.0
100.0
100.0
10.0
5.0
10.0
2.0
2.0
20.0
25.0
50.0
38.0
1.0
50.0
20.0
1.0
5.0
25.0
0.5
2.0
2.0
6.0
10.0
10.0
10.0
10.0
1.0
1.0
1.0
1.0
Minimum Breakthrough Detection Time ( Min)
> 240
> 240
> 240
59.4
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
> 240
118.5
> 240
> 240
> 240
> 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/K190736 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190736: Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190736
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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