510(k) · Cleared
ClearedPowder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhonghong Pulin Medical Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Nov 15, 2017 as substantially equivalent to K151750 (Kossan International Sdn Bhd, 2016) after a 145-day review. Its family tree reaches back 2 generations to 2009.
- Decided
- Nov 15, 2017
- Review
- 145 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K090412 (2009). No later device cites it as a predicate yet.
- Root · 2 generations backK090412 Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White).Gx Corporation Sdn Bhd · 2009
- 1 generation backK151750 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2016
- This deviceK171873 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non…Zhonghong Pulin Medical Products Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K090412 | Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White). | Gx Corporation Sdn Bhd | 2009 | — |
| −1 | K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2016 | — |
| 0 (this device) | K171873 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile… | Zhonghong Pulin Medical Products Co., Ltd. | 2017 | — |
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 |
|---|---|---|---|
| * | K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free…Summary page 4…r Free Nitrile Patient Examination Glove, Blue Colored, Non- Sterile, Tested for Use with Chemotherapy Drugs Copmany Name: Kossan International Sdn. Bhd. 510(K) Number: K151750 1 of4 ZHONG HONG 2|7l Device Description: The subject device in this 510(k) Notification is a Powder Free Nitr… | 2016 |
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 8 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K151750.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine (BCNU) 3.3 mg/ml 14.7…
Read the full statement (150 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Drug and Concentration Minimum Breakthrough Detection Time in Minutes
Carmustine (BCNU) 3.3 mg/ml 14.7
Cisplatin 1.0 mg/ml >240
Cyclophosphamide (Cytoxan) 20 mg/ml >240
Cytarabine 100 mg/ml >240
Dacarbazine (DTIC) 10.0 mg/ml >240
Doxorubicin Hydrochloride 2.0 mg/ml >240
Etoposide (Toposar) 20.0 mg/ml >240
Fluorouracil 50.0 mg/ml >240
Ifosfamide 50.0 mg/ml >240
Methotrexate 25 mg/ml >240
Mitomycin C 0.5 mg/ml >240
Mitoxantrone 2.0 mg/ml >240
Paclitaxel (Taxol) 6.0 mg/ml >240
Thiotepa 10.0 mg/ml 58.8
Vincristine Sulfate 1.0 mg/ml >240
Please note the following drugs have extremely low permeation times: Carmustine (BCNU) (3.3mg/ml) 14.7 minutes and Thiotepa (10 mg/ml) 58.8 minutes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171873: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, 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/K171873
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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