510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zibo Sinocare Plastic Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Feb 18, 2022 as substantially equivalent to K211714 (Hengchang (Dongying) Medical Technology Co., Ltd., 2021) after a 137-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- Feb 18, 2022
- Review
- 137 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 backK201390 Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use…Medline Industires, Inc. · 2020
- 1 generation backK211714 Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with…Hengchang (Dongying) Medical Technology Co., Ltd. · 2021
- This deviceK213306 Powder Free Nitrile Examination Gloves, Blue,Test For Use With…Zibo Sinocare Plastic Products Co., Ltd. · 2022
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 | K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with… | Medline Industires, Inc. | 2020 | — |
| −1 | K211714 | Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) | Hengchang (Dongying) Medical Technology Co., Ltd. | 2021 | — |
| 0 (this device) | K213306 | Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy… | Zibo Sinocare Plastic Products Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K211714 | Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)Summary page 4…with Chemotherapy Drugs) Company name: Hengchang (Dongying) Medical Technology Co., Ltd. 510(K) Number: K211714 4.0 Device Description: The powder free Nitrile Examination glove is a disposable Class 1 medical device made of Nitrile… | 2021 |
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 18 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy…
Read the full statement (179 words)
The Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
Test Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 16.9
Cisplatin 1.0 mg/ml(1,000 ppm) >240
Cyclophosphamide (Cytoxan) 20 mg/ml(20,000 ppm) >240
Dacarbazine 10 mg/ml(10,000 ppm) >240
Doxorubicin HCI 2.0 mg/ml(2,000 ppm) >240
Eotoside (Toposar) 20.0 mg/ml(20,000 ppm) >240
Fluorouracil 50.0 mg/ml(50,000 ppm) >240
Mechlorethamine 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
Paclitaxel (Taxol) 6.0 mg/ml(6,000 ppm) >240
Thio Tepa 10.0 mg/ml(10,000 ppm) 22.6
Vincristine Sulfate 1.0 mg/ml(1,000 ppm) >240
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3mg/mi 16.9 Minutes
Thio Tepa 10.0 mg/mi 22.6 Minutes.
Warning: Don't to use with either Carmustine or Thio Tepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213306: Powder Free Nitrile Examination Gloves, Blue,Test 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/K213306
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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