510(k) · Cleared
ClearedShamrock Powder Free 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
Pt. Shamrock Manufacturing Corpora · LZA Polymer Patient Examination Glove
Cleared on May 23, 2022 as substantially equivalent to K111248 (Yty Industry (Manjung) Sdn Bhd, 2011) after a 346-day review. Its family tree reaches back 3 generations to 2009. 1 later device descends from it.
- Decided
- May 23, 2022
- Review
- 346 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K082957 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK082957 Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color…Siam Sempermed Corp., Ltd. · 2009
- 2 generations backK101822 Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for…Sgmp Co., Ltd. · 2010
- 1 generation backK111248 Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue…Yty Industry (Manjung) Sdn Bhd · 2011
- This deviceK211810 Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use…Pt. Shamrock Manufacturing Corpora · 2022
- Descendant · cites it directly · 0 of its ownK232064 Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use…Isikel Manufacturing, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K232064Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy…Isikel Manufacturing, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K082957 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer… | Siam Sempermed Corp., Ltd. | 2009 | — |
| −2 | K101822 | Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with… | Sgmp Co., Ltd. | 2010 | — |
| −1 | K111248 | Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) | Yty Industry (Manjung) Sdn Bhd | 2011 | — |
| 0 (this device) | K211810 | Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with… | Pt. Shamrock Manufacturing Corpora | 2022 | — |
| +1 | K232064 | Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with… | Isikel Manufacturing, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K111248 | Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue)Summary page 5…Class: Class I Predicate Device: YTY Industry (Manjung): Non-sterile, Powder-free Nitrile Examination Gloves (Cobalt Blue) tested for use with Chemotherapy Drugs (K111248) Device Description: Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)… | 2011 |
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 |
|---|---|---|---|
| K232064 | Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy… | 2023 | 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 13 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232064 (Isikel Manufacturing, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K111248.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 purpose that is worn on examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl. Chemotherapy Drug and Permeation The following chemicals have been tested with these gloves: Chemotherapy…
Read the full statement (235 words)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner’s hand to
prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for
Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl.
Chemotherapy Drug and Permeation
The following chemicals have been tested with these gloves:
Chemotherapy Drug and Concentration Breakthrough Detection Time in Minutes
Carboplatin (Paraplatin), 10 mg/ml (10,000ppm) > 240 min.
Carmustine (BCNU), 3.3 mg/ml (3,300ppm) 46.6 min.
Chloroquine 50mg/ml (50,000ppm) > 240 min
Cisplatin, 1.0 mg/ml (1,000ppm) > 240 min
Cyclophosphamide (Cytoxan), 20.0mg/ml (20,000 ppm) > 240 min
Dacarbazine, 10.0mg/ml (10,000ppm) > 240 min
Docetaxel, 10mg/ml (10,000ppm) > 240 min
Doxorubicin HCI, 2.0mg/ml (2,000ppm) > 240 min
Etoposide, 20.0mg/ml (20,000ppm) > 240 min
Fluorouracil, 50.0mg/ml (50,000ppm) > 240 min
Ifosfamide, 50 mg/ml (50,000 ppm) > 240 min
Methotrexate, 25mg/ml (25,000 ppm) > 240 min
Mitomycin C, 0.5 mg/ml (500 ppm) > 240 min
Paclitaxel, 6.0 mg/ml (6,000 ppm) > 240 min
Thiotepa, 10.0mg/ml (10,000ppm) 64.8 min
Vincristine Sulfate, 1 mg/ml (1,000 ppm) > 240 min
Fentanyl Citrate Injection 100mcg/2ml (50mcg/1ml) > 240 min
Please note that the following drugs that have low permeation time are:
Carmustine (BCNU), 3.3 mg/ml 46.6 min
Thiotepa, 10.0mg/ml 64.8 min
CAUTION: Testing showed an average of breakthrough time of 46.6 min for Carmustine and 64.8 min for Thiotepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211810 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211810: Shamrock Powder Free 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/K211810
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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