510(k) · Cleared
ClearedNitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anhui Intco Medical Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Mar 1, 2024 as substantially equivalent to K200671 (Ansell Healthcare Products, LLC, 2020) after a 295-day review. Its family tree reaches back 2 generations to 2008. 1 later device descends from it.
- Decided
- Mar 1, 2024
- Review
- 295 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K082457 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK082457 Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination…Ansell Healthcare Products, Inc. · 2008
- 1 generation backK200671 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile…Ansell Healthcare Products, LLC · 2020
- This deviceK231365 Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored…Anhui Intco Medical Products Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK250630 Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for…Basic Medical Technology, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250630Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with…Basic Medical Technology, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082457 | Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination Gloves… | Ansell Healthcare Products, Inc. | 2008 | — |
| −1 | K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue… | Ansell Healthcare Products, LLC | 2020 | — |
| 0 (this device) | K231365 | Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and… | Anhui Intco Medical Products Co., Ltd. | 2024 | — |
| +1 | K250630 | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with… | Basic Medical Technology, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink…Summary page 6…oves 3. Device Classification Name: Patient Examination gloves (21 CFR 880.6250) 4. Device Class: Class I. 5. Product Code: LZA, LZC,OPJ,QDO. 6. Predicate Devices: K200671 – Ansell Healthcare Products LLC Powder-Free Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink Colored T… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250630 | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with… | 2025 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K250630 (Basic Medical Technology, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K200671.
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?
A powder-free 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. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Test Chemotherapy drug & Concentration Average…
Read the full statement (169 words)
A powder-free 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. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
Test Chemotherapy drug & Concentration Average Breakthrough Detection Time (Minutes)
Carmustine (BCNU)(3.3 mg/ml) 12.1 min.
Cyclophosphamide (Cytoxan) (20.0 mg/ml) >240 min.
Doxorubicin Hydrichloride (2.0mg/) >240 min.
Etoposide (Toposar) (20.0mg/ml) >240 min.
Fluorouracil (50.0mg/ml) >240 min.
Methotrexate (25.0 mg/ml) >240 min.
Paclitaxel (Taxol) (6.0 mg/ml) >240 min.
Thiotepa(10.0 mg/ml) 10.1 min.
Vincristine Sulfate(1.0 mg/ml) >240 min.
Cisplatin(1.0 mg/ml) >240 min.
Dacarbazine(l0 mg/ml) >240 min.
Mitomycin C(0.5 mg/ml) >240 min.
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 12.1 minutes and Thiotepa:10.1 minutes.
Warning: Do not use with Carmustine or Thiotepa
Fentanyl Citrate & Concentration Minimum Breakthrough Detection Times
Fentanyl Citrate Injection(l00 mcg/2ml) >240 min.
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/K231365 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231365: Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231365
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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