510(k) · Cleared
ClearedNitrile Cornflower Blue Powder-Free Examination Gloves with Tested for Use with Chemotherapy Drug Labeling Claim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Inc. · LZA Polymer Patient Examination Glove
Cleared on Dec 16, 2010 as substantially equivalent to K022765 (Allegiance Healthcare Corp., 2002) after a 43-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Dec 16, 2010
- Review
- 43 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022765 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
- This deviceK103249 Nitrile Cornflower Blue Powder-Free Examination Gloves with Tested…Cardinal Health, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK232764 Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use…Eco Medi Glove Sdn. Bhd. · 2024
- Descendant · cites it directly · 0 of its ownK122696 Powder-Free Nitrile Examination Gloves (Cool Blue)Cardinal Health, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022765 | Nitrile Powder-Free Examination Gloves | Allegiance Healthcare Corp. | 2002 | — |
| 0 (this device) | K103249 | Nitrile Cornflower Blue Powder-Free Examination Gloves with Tested for Use… | Cardinal Health, Inc. | 2010 | — |
| +1 | K232764 | Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with… | Eco Medi Glove Sdn. Bhd. | 2024 | — |
| +1 | K122696 | Powder-Free Nitrile Examination Gloves (Cool Blue) | Cardinal Health, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K022765 | Nitrile Powder-Free Examination GlovesSummary page 2…epa (10 mg/ml) Predicate Devices: Nitrile Blue Powder-Free Examination Gloves with Tested for Use with Chemotherapy Drug Labeling Claim previously cleared under 510(k) K022765 (product code LZA); Substantial Equivalence: These Nitrile powder-free examination gloves are substantially equivalent to the p… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug and Minimum Breakthrough Detection Time Concentration…
Read the full statement (147 words)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug and Minimum Breakthrough Detection Time
Concentration in Minutes, 0.01 pgcmzlminute
1. Carmustine (BCNU) (3.3 mg/ml) 7.28
2. Cisplastin, (1.0mg/ml) >240
3. Cyclophosphamide (20 mg/ml) >240
4. Doxorubicin HCI (2.0 mg/ml) >240
5. Etoposide (Toposar) (20 mg/ml) >240
6. S-Fluorouracil (50 mg/ml) >240
7. Methotrexate (25 mg/ml) >240
8. Paclitaxel (Taxol) (6.0 mg/mi) >240
9. Thiotepa (10 mg/ml) 2.67
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes:
Carmustine (BCNU) (3.3 mg/ml)
Thiotepa (10 mg/ml)
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/K103249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103249: Nitrile Cornflower Blue Powder-Free Examination Gloves with Tested for Use with Chemotherapy Drug Labeling Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103249
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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