510(k) · Cleared
ClearedMemorialTM Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Us Glove Supply · LZA Polymer Patient Examination Glove
Cleared on Jul 4, 2023 as substantially equivalent to K172525 (Central Medicare Sdn Bhd, 2017) after a 20-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Jul 4, 2023
- Review
- 20 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042805 (2004). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 4 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 3 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 2 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 1 generation backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- This deviceK231740 MemorialTM GlovesUs Glove Supply · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −4 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −3 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −2 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −1 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| 0 (this device) | K231740 | MemorialTM Gloves | Us Glove Supply | 2023 | — |
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 |
|---|---|---|---|
| * | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy…Summary page 5…General Hospital and Personal Use Devices 5.4 Legally marketed device(s) to which equivalence is claimed Predicate Device: 510(k) K172525 Trade/Proprietary Name Blue Non-Sterile Powder Free Nitrile Examination Gloves T… | 2017 |
| † | K223559 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy… | 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 19 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- None of the 6 ancestors has a recall.
- 4 other devices also cite its predicate K172525.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
These Powder Free, Nitrile Examination Gloves are a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Permeation The following chemicals have been tested with these…
Read the full statement (228 words)
These Powder Free, Nitrile Examination Gloves are a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves:
Tested Chemotherapy Drug and Concentration Minimum Breakthrough Detection time
Cyclophosphamide (20.0 mg/ml) No breakthrough for up to 240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml) No breakthrough for up to 240 minutes
Etoposide (20.0 mg/ml) No breakthrough for up to 240 minutes
5-Fluorouracil (50.0 mg/ml) No breakthrough for up to 240 minutes
Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough for up to 240 minutes
Cisplatin (1.0 mg/ml) No breakthrough for up to 240 minutes
Dacarbazine (10.0 mg/ml) No breakthrough for up to 240 minutes
Methotrexate (25 mg/ml) No breakthrough for up to 240 minutes
Mitomycin C (0.5 mg/ml) No breakthrough for up to 240 minutes
Vincristine Sulfate (1.0 mg/ml) No breakthrough for up to 240 minutes
Carmustine (BCNU) (3 .3 mg/ml) Min minutes before breakthrough =14.9
Thio-Tepa (10.0 mg/ml) Min minutes before breakthrough =37.8
Waming Not For use with Carmustine Waming Not For use with Thio-Tepa
*Please note that the following drugs have low permeation times:
Carmustine (BCNU): 14.9 Minutes and Thio-Tepa: 37.8 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/K231740 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231740: MemorialTM Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231740
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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