510(k) · Cleared
ClearedBlue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Central Medicare Sdn Bhd · LZC Medical Glove, Specialty
Cleared on Nov 13, 2017 as substantially equivalent to K163146 (Hebei Hongsen Plastics Technology Co, Ltd., 2017) after an 84-day review. Its family tree reaches back 4 generations to 2004. 39 later devices descend from it.
- Decided
- Nov 13, 2017
- Review
- 84 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042805 (2004). 5 ancestors in all. 39 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 3 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 2 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 1 generation backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- This deviceK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- Descendant · cites it directly · 17 of its ownK173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2018
- Descendant · 2 generations on · 13 of its ownK182600 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2018
- Descendant · cites it directly · 9 of its ownK180646 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with…Halyard Health · 2018
- Descendant · cites it directly · 8 of its ownK201390 Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use…Medline Industires, Inc. · 2020
- Descendant · 3 generations on · 5 of its ownK213440 Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested…Luliang Hongruida Health Protection Technology Co., Ltd. · 2022
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K173942Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy…Central Medicare Sdn Bhd · 2018 · cites it directly17descendants
- K182600Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)Better Care Plastic Technology Co., Ltd. · 2018 · 2 generations on13descendants
- K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsHalyard Health · 2018 · cites it directly9descendants
- K201390Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy…Medline Industires, Inc. · 2020 · cites it directly8descendants
- K213440Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with…Luliang Hongruida Health Protection Technology Co., Ltd. · 2022 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −3 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −2 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −1 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| 0 (this device) | 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 | — |
| +2 | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs… | Better Care Plastic Technology Co., Ltd. | 2018 | — |
| +1 | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with… | Halyard Health | 2018 | — |
| +1 | K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with… | Medline Industires, Inc. | 2020 | — |
| +3 | K213440 | Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use… | Luliang Hongruida Health Protection Technology Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 11 | 0 |
| 2022 | 11 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 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 LZC? 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 LZC device
- #1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 5 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 |
|---|---|---|---|
| * | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy DrugsSummary page 5…e, a specialty chemotherapy glove, Hebei Hongsen Plastics Technology Co, Ltd’s POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs (K163146). The proposed device will be known as Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use w… | 2017 |
What descends from it? (39)
See all 395 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy… | 2018 | 17 |
| K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | 2018 | 9 |
| K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy… | 2020 | 8 |
| K231740 | MemorialTM Gloves | 2023 | 0 |
| K212639 | Disposable Medical Nitrile Examination Gloves (Non sterile) | 2021 | 0 |
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 13 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K173942 (Central Medicare Sdn Bhd, 2018) has gone furthest, with 17 descendants of its own.
- 1 other device also cites its predicate K163146.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 2025
MAUDE reports naming product code LZC, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 166 | 1 | 0 |
| 2009 | 5 | 253 | 0 | 1 |
| 2010 | 5 | 68 | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 4 | 149 | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 258 | 0 | 5 |
| 2017 | 6 | 121 | 0 | 7 |
| 2018 | 6 | 105 | 0 | 6 |
| 2019 | 7 | 200 | 0 | 8 |
| 2020 | 3 | 167 | 0 | 1 |
| 2021 | 3 | 94 | 1 | 2 |
| 2022 | 7 | 85 | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172525 · printed Nov 4, 2026
Cite this page
510(k) Report. “K172525: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K172525
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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