510(k) · Cleared
ClearedPowder Free Blue 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
Hebei Titans Hongsen Medical Technology Co., Ltd. · LZC Medical Glove, Specialty
Cleared on Aug 10, 2018 as substantially equivalent to K163146 (Hebei Hongsen Plastics Technology Co, Ltd., 2017) after a 102-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Aug 10, 2018
- Review
- 102 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. No later device cites it as a predicate yet.
- 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 deviceK181130 Powder Free Blue Nitrile Examination Gloves, Tested for Use with…Hebei Titans Hongsen Medical Technology Co., Ltd. · 2018
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) | K181130 | Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy… | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2018 | — |
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 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 7…ollowing drugs have low permeation times: Carmustine (BCNU): 8.5 minutes and Thiotepa: 36.1 minutes 5. Predicate Device Identification 510(k) Number: K163146 Product Name: POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs Manufacturer: HEBEI HONGSEN PLAST… | 2017 |
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 14 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.
- 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. 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?
The Powder Free Blue Nitrile Examination 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…
Read the full statement (264 words)
The Powder Free Blue Nitrile Examination 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
Bleomycin 15 mg/ml (15,000 ppm) >240
Busulfan 6 mg/ml (6,000 ppm) >240
Carboplatin 10 mg/ml (10,000ppm) >240
Carmustine (BCNU) 3.3 mg/ml (3,300ppm) 8.5 (12.7, 13.4, 8.5)
Cisplatin 1.0 mg/ml (1,000ppm) >240
Cyclophosphamide(Cytoxan) 20.0 mg/ml (20,000ppm) >240
Cytarabine 100 mg/ml (100,000ppm) >240
Cytovene 10 mg/ml (10,000ppm) >240
Dacarbazine(DTIC) 10.0 mg/ml (10,000ppm) >240
Daunorubicin 5 mg/ml (5,000ppm) >240
Docetaxel 10.0 mg/ml(10,000ppm) >240
Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) >240
Ellence 2 mg/ml (2,000ppm) >240
Etoposide(Toposar) 20.0 mg/ml(20,000ppm) >240
Fludarabine 25 mg/ml(25,000ppm) >240
Fluorouracil 50 mg/ml(50,000ppm) >240
Gemcitabine (Gemzar) 38 mg/ml(38,000ppm) >240
Idarubicin 1 mg/ml (1,000ppm) >240
Ifosfamide 50.0 mg/ml (50,000ppm) >240
Irinotecan 20.0 mg/ml (20,000ppm) >240
Mechlorethamine HCI 1.0 mg/ml (1,000ppm) >240
Melphalan 5 mg/ml (5,000ppm) >240
Methotrexate 25mg/ml (25,000ppm) >240
Mitomycin C 0.5 mg/ml (500 ppm) >240
Mitoxantrone 2.0 mg/ml(2,000ppm) >240
Oxaliplatin 2.0 mg/ml(2,000ppm) >240
Paclitaxel (Taxol) 6.0 mg/ml(6,000ppm) >240
Rituximab 10 mg/ml(10,000ppm) >240
Thiotepa 10.0 mg/ml (10,000ppm) 36.1 (51.2, 36.1, 45.6)
Trisenox 0.1 mg/ml (100ppm) >240
Vincristine Sulfate 1.0 mg/ml (1,000ppm) >240
Vinorelbine 10 mg/ml(10,000ppm) >240
*Please note that the following drugs have low permeation times:
Carmustine (BCNU): 8.5 minutes and Thiotepa: 36.1 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181130: Powder Free Blue 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/K181130
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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