510(k) · Cleared
ClearedNitrile Powder Free 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
Jiangsu Yanfang Medical Technology Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Oct 5, 2021 as substantially equivalent to K190736 (Ever Growth (Vietnam) Co., Ltd., 2019) after a 97-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- Oct 5, 2021
- Review
- 97 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 backK190736 Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested…Ever Growth (Vietnam) Co., Ltd. · 2019
- This deviceK212036 Nitrile Powder Free Examination Gloves,Tested For Use With…Jiangsu Yanfang Medical 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 | K190736 | Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use… | Ever Growth (Vietnam) Co., Ltd. | 2019 | — |
| 0 (this device) | K212036 | Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs | Jiangsu Yanfang Medical 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 |
|---|---|---|---|
| * | K190736 | Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With…Summary page 5…th (Vietnam) Co., Ltd. Device: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs 510(k) number: K190736 1 of 8… | 2019 |
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 1.8 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K190736.
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?
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes Carboplatin…
Read the full statement (248 words)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs
Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes
Carboplatin 10.0 mg/ml(10,000 ppm) > 240 Minutes
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 16.4 Minutes
Cisplatin 1.0 mg/ml(1,000 ppm) > 240 Minutes
Cyclophosphamide (Cytoxan) 20.0 mg/ml(20,000 ppm) > 240 Minutes
Dacarbazine 10.0 mg/ml(10,000 ppm) > 240 Minutes
Docetaxel 10.0 mg/ml(10,000 ppm) > 240 Minutes
Doxorubicin HCI 2.0 mg/ml(2,000 ppm) > 240 Minutes
Epirubicin HCI 2.0 mg/ml(2,000 ppm) > 240 Minutes
Etoposide 20.0 mg/ml(20,000 ppm) > 240 Minutes
Fluorouracil 50.0 mg/ml(50,000 ppm) > 240 Minutes
Gemcitabine 38.0 mg/ml(38,000 ppm) > 240 Minutes
Ifosfamide 50.0 mg/ml(50,000 ppm) > 240 Minutes
Irinotecan 20.0 mg/ml(20,000 ppm) > 240 Minutes
Methotrexate 25.0 mg/ml(25,000 ppm) > 240 Minutes
Miromycin C 0.5 mg/ml(500 ppm) > 240 Minutes
Mitoxantrone 2.0 mg/ml(2,000 ppm) > 240 Minutes
Oxaliplatin 5.0 mg/ml(5,000 ppm) > 240 Minutes
Paclitaxel 6.0 mg/ml(6,000 ppm) > 240 Minutes
ThioTepa 10.0 mg/ml(10,000 ppm) 98.6 Minutes
Vincristine Sulface 1.0 mg/ml(1,000 ppm) > 240 Minutes
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:
Carmustine (BCNU) 3.3 mg/ml 16.4 Minutes
Thio Tepa 10.0 mg/ml 98.6 Minutes
Warning: Please do not use with Carmustine (BCNU).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212036 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212036: Nitrile Powder Free 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 5, 2026. https://510kreport.com/device/K212036
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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