510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanxi Hongjin Plastic Technology Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Oct 27, 2021 as substantially equivalent to K182600 (Better Care Plastic Technology Co., Ltd., 2018) after a 155-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- Oct 27, 2021
- Review
- 155 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K042805 (2004). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 6 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 5 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 4 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 3 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- 2 generations backK173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2018
- 1 generation backK182600 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2018
- This deviceK211604 Powder Free Nitrile Examination Gloves (Blue), Tested for Use with…Shanxi Hongjin Plastic Technology Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −6 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −5 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −4 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −3 | 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 | — |
| −1 | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs… | Better Care Plastic Technology Co., Ltd. | 2018 | — |
| 0 (this device) | K211604 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Shanxi Hongjin Plastic Technology Co., Ltd. | 2021 | — |
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 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 |
|---|---|---|---|
| * | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)Summary page 5…Class I 3. Predicate Device Information: Better Care Plastic Technology Co., Ltd Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) (K182600) 4. Device Description: Powder Free Nitrile Examination Gloves(Blue), Tested for Use with Chemotherapy Drugs are Class I Patient… | 2018 |
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 17 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K182600.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Powder Free Nitrile Examination Gloves (Blue), 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 and will be labeled with a statement of compliance and a summary of the testing results. Chemotherapy Drug Permeation The following chemicals have been…
Read the full statement (241 words)
Powder Free Nitrile Examination Gloves (Blue), 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 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:
* Please note that the following drugs have extremely low permeation times:
Chemotherapy Drug Minimum BDT (Minutes)
Bleomycin (15.0mg/ml) >240
Bortezomib (Velcade) lmg/ml >240
Busulfan (6.0mg/ml) >240
Carboplatin, (10.0mg/ml) >240
Carmustine(BCNU) (3.3 mg/ml) 7.0
Chloroquine, (50.0mg/ml) >240
Cisplatin (lmg/ml) >240
Cyclophosphamide (Cytoxan) (20mg/ml) >240
Cyclosporin, (100.Omg/ml) >240
Cytarabine, (100.0mg/ml) >240
Dacarbazine (10mg/ml) >240
Daunorubicin, HCL (5.Omg/ml) >240
Docetaxel, (10.Omg/ml) >240
Doxorubicin HCL (2mg/ml) >240
Epirubicin HCL (Ellence), (2.0mg/ml) >240
Etoposide (20mg/ml) >240
Fludarabine, (25.0mg/ml) >240
Fluorouracil (50mg/ml) >240
Gemcitabine (38.0mg/ml) >240
Idarubicin HCL (1.0mg/ml) >240
Ifosfamide, (50.Omg/ml) >240
Irinotecan, (20.0mg/ml) >240
Mechlorethamine HCI, (1.0mg/ml) >240
Melphalan, (5.0mg/ml) >240
Methotrexate (25mg/ml) >240
Mitomycin C, (0.5mg/ml) >240
Mitoxantrone, (2.0mg/ml) >240
Oxaliplatin, (5.Omg/ml) >240
Paclitaxel (Taxol) (6mg/ml) >240
Paraplatin, (10.0mg/ml) >240
Retrovir, (10.0mg/ml) >240
Rituximab, (10.0mg/ml) >240
Thio Tepa (10mg/ml) 23.0
Topotecan HCL, (1.0mg/ml) >240
Trisonex, (1.0mg/ml) >240
Vincristine, (1.0mg/ml) >240
Please note that the following drugs have extremely low permeation times:
Carmustine (BCNU): 7.0 minutes, Thio Tepa: 23 minutes,
Warning: Do not use with Carmustine (BCNU) and Thio Tepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211604: Powder Free Nitrile Examination Gloves (Blue), 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/K211604
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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