510(k) · Cleared
ClearedPOWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hebei Hongsen Plastics Technology Co, Ltd. · LZC Medical Glove, Specialty
Cleared on Feb 13, 2017 as substantially equivalent to K141982 (Wrp Asia Pacific Sdn. Bhd., 2015) after a 96-day review. Its family tree reaches back 3 generations to 2004. 41 later devices descend from it.
- Decided
- Feb 13, 2017
- Review
- 96 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042805 (2004). 4 ancestors in all. 41 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 2 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 1 generation backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- This deviceK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- Descendant · cites it directly · 39 of its ownK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- Descendant · 2 generations on · 17 of its ownK173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2018
- Descendant · 3 generations on · 13 of its ownK182600 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 9 of its ownK180646 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with…Halyard Health · 2018
- Descendant · 2 generations on · 8 of its ownK201390 Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use…Medline Industires, Inc. · 2020
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy…Central Medicare Sdn Bhd · 2017 · cites it directly39descendants
- K173942Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy…Central Medicare Sdn Bhd · 2018 · 2 generations on17descendants
- K182600Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)Better Care Plastic Technology Co., Ltd. · 2018 · 3 generations on13descendants
- K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsHalyard Health · 2018 · 2 generations on9descendants
- K201390Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy…Medline Industires, Inc. · 2020 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −2 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −1 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| 0 (this device) | 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 | — |
| +2 | K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2018 | — |
| +3 | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs… | Better Care Plastic Technology Co., Ltd. | 2018 | — |
| +2 | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with… | Halyard Health | 2018 | — |
| +2 | K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with… | Medline Industires, Inc. | 2020 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 4 | 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 |
|---|---|---|---|
| * | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for…Summary page 7…3‐2 510(k) Summary 5. Predicate Device Identification 510(k) Number: K141982 Product Name: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemother… | 2015 |
What descends from it? (41)
See all 412 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 13 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K172525 (Central Medicare Sdn Bhd, 2017) has gone furthest, with 39 descendants of its own.
- 6 other devices also cite its predicate K141982.
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?
The POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following chemicals have been…
Read the full statement (232 words)
The POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner.
The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with proposed device.
Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes
Fluorouracil 50.0 mg/ml (50,000 ppm) > 240
Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) > 240
Cyclophosphamid (Cytoxan) 20.0 mg/ml (20,000 ppm) > 240
*Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 45.0
*Thiotepa 10.0 mg/ml (10,000 ppm) 30.0
Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) > 240
Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) > 240
Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) > 240
Cisplatin 1.0 mg/ml (1,000 ppm) > 240
Carboplatin 10.0 mg/ml (10,000 ppm) > 240
Docetaxel 10.0 mg/ml (10,000 ppm) > 240
Ifosfamide 50.0 mg/ml (50,000 ppm) > 240
Irinotecan 20.0 mg/ml (20,000 ppm) > 240
Mechlorethamine HCL 1.0 mg/ml (1,000 ppm) > 240
Methotrexate 25.0 mg/ml (25,000 ppm) > 240
Mitomycin C 0.5 mg/ml (500 ppm) > 240
Mitoxantrone 2.0 mg/ml (2,000 ppm) > 240
Vincristine Sulfate 1.0 mg/ml (1,000 ppm) > 240
* Please note that the following drugs have low permeation times:
Carmustine (BCNU): 45 minutes and Thiotepa: 30 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163146 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163146: POWDER FREE Blue Nitrile GLOVES, 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/K163146
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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