510(k) · Cleared
ClearedPowder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anhui Powerguard Technology Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Jan 12, 2024 as substantially equivalent to K223903 (Semperit Investments Asia Pte, Ltd., 2023) after a 72-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jan 12, 2024
- Review
- 72 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000323 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK000323 Nitrile Patient Examination Glove (Blue Color) Powder Free, Non…Siam Sempermed Corp., Ltd. · 2000
- 5 generations backK060753 Non-Sterile, Powder Free Nitrile Examination Glove, Blue with…Siam Sempermed Corp., Ltd. · 2006
- 4 generations backK080520 Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer…Siam Sempermed Corp., Ltd. · 2008
- 3 generations backK083755 Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue…Siam Sempermed Corp., Ltd. · 2009
- 2 generations backK171378 Non-Sterile, Single use, Powder-free examination glove tested for…Semperit Investments Asia Pte, Ltd. · 2017
- 1 generation backK223903 Non-Sterile, Single use, Powder-free examination glove, Blue, tested…Semperit Investments Asia Pte, Ltd. · 2023
- This deviceK233520 Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested…Anhui Powerguard Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000323 | Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile | Siam Sempermed Corp., Ltd. | 2000 | — |
| −5 | K060753 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating… | Siam Sempermed Corp., Ltd. | 2006 | — |
| −4 | K080520 | Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with… | Siam Sempermed Corp., Ltd. | 2008 | — |
| −3 | K083755 | Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color… | Siam Sempermed Corp., Ltd. | 2009 | — |
| −2 | K171378 | Non-Sterile, Single use, Powder-free examination glove tested for use with… | Semperit Investments Asia Pte, Ltd. | 2017 | — |
| −1 | K223903 | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use… | Semperit Investments Asia Pte, Ltd. | 2023 | — |
| 0 (this device) | K233520 | Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with… | Anhui Powerguard Technology Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K223903 | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with…Summary page 5…atient Examination Glove Classification: Class I Product code: LZA, LZC, OPJ, QDO Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital C. Predicate device: K223903 Non‐Sterile, Single use, Powder‐free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SEMPERIT INVEST… | 2023 |
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 24 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K223903.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Chemotherapy drug Concentration Minimum Breakthrough Detection Time Carmustine ( 3.3mg/mL 3,300 ppm) 11.1 min Cisplatin ( 1.0 mg/mL 1,000 ppm) >240 min…
Read the full statement (193 words)
The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs are:
Chemotherapy drug Concentration Minimum Breakthrough Detection Time
Carmustine ( 3.3mg/mL 3,300 ppm) 11.1 min
Cisplatin ( 1.0 mg/mL 1,000 ppm) >240 min
Cyclophosphamide (20 mghmL 20,000 ppm) >240 min
Cytarabine (Cytosine) (100 mg/nL 100,000 ppm) >240 min
Dacarbazine (10 mg/mL 10,000 ppm) >240 min
Doxorubicin (Adriamycin) (2.0 mg/mL 2,000 ppm) >240 min
Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min
Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min
Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min
Methotrexate (25.0 mg/mL 25,000 ppm) >240 min
Mitomycin C (0.5 mg/mL 500 ppm) >240 min
Mitoxantrone HCL (2.0 mg/mL 2,000 ppm >240 min
Paclitaxel (6.0 mg/mL 6,000 ppm) >240 min
Thiotepa (10.0 mg/mL 10,000 ppm) 34.8 min
Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min
Fentanyl Citrate Injection (100 mcg/2mL) >240 min
Note: Carmustine and Thiotepa have extremely low permeation times of 11.1 and 34.8 minutes respectively.
Warning: Do Not Use with Carmustine, Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233520 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233520: Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233520
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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