510(k) · Cleared
ClearedPowder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isikel Manufacturing, LLC · LZA Polymer Patient Examination Glove
Cleared on Oct 2, 2023 as substantially equivalent to K211810 (Pt. Shamrock Manufacturing Corpora, 2022) after an 83-day review. Its family tree reaches back 4 generations to 2009.
- Decided
- Oct 2, 2023
- Review
- 83 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K082957 (2009). No later device cites it as a predicate yet.
- Root · 4 generations backK082957 Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color…Siam Sempermed Corp., Ltd. · 2009
- 3 generations backK101822 Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for…Sgmp Co., Ltd. · 2010
- 2 generations backK111248 Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue…Yty Industry (Manjung) Sdn Bhd · 2011
- 1 generation backK211810 Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use…Pt. Shamrock Manufacturing Corpora · 2022
- This deviceK232064 Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use…Isikel Manufacturing, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K082957 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer… | Siam Sempermed Corp., Ltd. | 2009 | — |
| −3 | K101822 | Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with… | Sgmp Co., Ltd. | 2010 | — |
| −2 | K111248 | Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) | Yty Industry (Manjung) Sdn Bhd | 2011 | — |
| −1 | K211810 | Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with… | Pt. Shamrock Manufacturing Corpora | 2022 | — |
| 0 (this device) | K232064 | Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with… | Isikel Manufacturing, LLC | 2023 | — |
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 |
|---|---|---|---|
| * | K211810 | Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy…Summary page 5…Submission: New Device 510(k) 2 Predicate Device K211810 Manufacturer PT. Shamrock Manufacturing Corporation Device Name Shamrock Powder Free… | 2022 |
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 14 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- None of the 4 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. 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?
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by…
Read the full statement (192 words)
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a
disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between
patient and examiner.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate in accordance with ASTM
D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by Chemotherapy Drugs.
Chemotherapy Drug Concentration Breakthrough Detection Time
Carmustine 3.3 mg/ml (3,300 ppm) 16.2 (16.2,21.6,21.9) min.
Cisplatin 1 mg/ml (1,000 ppm) >240 min.
Cyclophosphamide 20 mg/ml (20,000 ppm) >240 min.
Dacarbazine 10 mg/ml (10,000 ppm) >240 min.
Doxorubicin HCL 2 mg/ml (2,000 ppm) >240 min.
Etoposide 20 mg/ml (20,000 ppm) >240 min.
Fluorouracil 50 mg/ml (50,000 ppm) >240 min.
Mitomycin C 0.5 mg/ml (500 ppm) >240 min.
Paclitaxel 60 mg/ml (6,000 ppm) >240 min.
Thiotepa 10 mg/ml (10,000 ppm) 40.6 (70.6,40.6,40.6) min.
Vincristine Sulfate 1 mg/ml (1,000 ppm) >240 min.
Fentanyl/Citrate Injection 100 mcg/2mL >240min.
Please note the following drugs have low permeation times:
Carmustine 3.3 mg/ml (3,300 ppm) 16.2 minutes
Thiotepa 10 mg/ml (10,000 ppm) 40.6 minutes
Warning: Do Not Use with Carmustine and Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232064: Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232064
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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