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 Mar 5, 2018 as substantially equivalent to K172525 (Central Medicare Sdn Bhd, 2017) after a 69-day review. Its family tree reaches back 5 generations to 2004. 17 later devices descend from it.
- Decided
- Mar 5, 2018
- Review
- 69 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042805 (2004). 6 ancestors in all. 17 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 4 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 3 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 2 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 1 generation backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- This deviceK173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2018
- Descendant · cites it directly · 13 of its ownK182600 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 5 of its ownK213440 Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested…Luliang Hongruida Health Protection Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 5 of its ownK210944 Powder Free Nitrile Examination Glove, Tested for Use with…Harbour Health, LLC · 2021
- Descendant · 3 generations on · 3 of its ownK223559 Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For…Nephron Pharmaceuticals Corporation · 2023
- Descendant · 4 generations on · 2 of its ownK231349 Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For…Nephron Nitrile, LLC · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K182600Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)Better Care Plastic Technology Co., Ltd. · 2018 · cites it directly13descendants
- K213440Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with…Luliang Hongruida Health Protection Technology Co., Ltd. · 2022 · 2 generations on5descendants
- K210944Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)Harbour Health, LLC · 2021 · 2 generations on5descendants
- K223559Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy…Nephron Pharmaceuticals Corporation · 2023 · 3 generations on3descendants
- K231349Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy…Nephron Nitrile, LLC · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −4 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −3 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −2 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −1 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| 0 (this device) | K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2018 | — |
| +1 | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs… | Better Care Plastic Technology Co., Ltd. | 2018 | — |
| +2 | K213440 | Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use… | Luliang Hongruida Health Protection Technology Co., Ltd. | 2022 | — |
| +2 | K210944 | Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs… | Harbour Health, LLC | 2021 | — |
| +3 | K223559 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With… | Nephron Pharmaceuticals Corporation | 2023 | — |
| +4 | K231349 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With… | Nephron Nitrile, LLC | 2023 | — |
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 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 6 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 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 |
|---|---|---|---|
| * | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy…Summary page 5…Chemotherapy Drugs 510(k) Number: K173942 Predicate Device K172525 510(k) Number: 4.0 Description of The Device: Blue Non Sterile Powder Free Nitrile Examination Gloves Te… | 2017 |
What descends from it? (17)
See all 172 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 14 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K182600 (Better Care Plastic Technology Co., Ltd., 2018) has gone furthest, with 13 descendants of its own.
- 4 other devices also cite its predicate K172525.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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. Chemotherapy Drug Permeation The following chemicals…
Read the full statement (281 words)
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.
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves:
Bleomycin Sulfate: 15 mg/ml, >240 minutes
Busulfan: 6 mg/ml, >240 minutes
Carboplatin: 10 mg/ml, >240 minutes
Carmustine: 3.3 mg/ml, 12.4 minutes
Cisplatin: 1 mg/ml, >240 minutes
Chloroquine: 50 mg/ml, >240 minutes
Cyclophosphamide: 20 mg/ml, >240 minutes
Cyclosporin: 100 mg/ml, >240 minutes
Cytarabine HCI: 100 mg/ml, >240 minutes
Dacarbazine: 10 mg/ml, >240 minutes
Daunorubicin HCI: 5 mg/ml, >240 minutes
Docetaxel: 10 mg/ml, >240 minutes
Doxorubicin Hydrochloride: 2 mg/ml, >240 minutes
Epirubicin (Ellence): 2 mg/ml, >240 minutes
Etoposide: 20 mg/ml, >240 minutes
Fludarabine: 25 mg/ml, >240 minutes
Fluorouracil: 50 mg/ml, >240 minutes
Gemcitabine: 38 mg/ml, >240 minutes
Idarubicin: 1 mg/ml, >240 minutes
Ifosfamide: 50 mg/ml, >240 minutes
Irinotecan: 20 mg/ml, >240 minutes
Mechlorethamine HCI: 1 mg/ml, >240 minutes
Melphalan: 5 mg/ml, >240 minutes
Methotrexate: 25 mg/ml, >240 minutes
Mitomycin: 0.5 mg/ml, >240 minutes
Mitoxantrone: 2 mg/ml, >240 minutes
Oxaliplatin: 5 mg/ml, >240 minutes
Paclitaxel: 6 mg/ml, >240 minutes
Paraplatin: 10 mg/ml, >240 minutes
Retrovir: 10 mg/ml, >240 minutes
Rituximab: 10 mg/ml, >240 minutes
Thiotepa: 10 mg/ml, 24.4 minutes
Topotecane: 1 mg/ml, >240 minutes
Trisonex: 1 mg/ml, >240 minutes
Velcade: 1 mg/ml, >240 minutes
Vincristine Sulfate: 1 mg/ml, >240 minutes
*Please note that the following drugs have extremely low permeation times:
Carmustine: 12.4 minutes and Thiotepa: 24.4 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173942: 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 6, 2026. https://510kreport.com/device/K173942
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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