510(k) · Cleared
ClearedMediguard Nitrile Examination Glove- Blue (Tested for Use with Chemotherapy Drugs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · LZA Polymer Patient Examination Glove
Cleared on Feb 22, 2010 after an 81-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Feb 22, 2010
- Review
- 81 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK093726 Mediguard Nitrile Examination Glove- Blue (Tested for Use with…Medline Industries, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK102096 Powder Free Nitrile Examination Gloves, BlueSyntex Healthcare Products Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK140816 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2014
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 |
|---|---|---|---|---|---|
| 0 (this device) | K093726 | Mediguard Nitrile Examination Glove- Blue (Tested for Use with Chemotherapy… | Medline Industries, Inc. | 2010 | — |
| +1 | K102096 | Powder Free Nitrile Examination Gloves, Blue | Syntex Healthcare Products Co., Ltd. | 2010 | — |
| +2 | K140816 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs… | Better Care Plastic Technology Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102096 | Powder Free Nitrile Examination Gloves, Blue | 2010 | 1 |
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?
- Of its descendants, K102096 (Syntex Healthcare Products Co., Ltd., 2010) has gone furthest, with 1 descendant of its own.
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?
The Mediguard Powder-Free Nitrite Examination Glove (tested.for use with chemotherapy drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
5-Fluorouracil — >240 min.
Etoposide (Toposar) — >240 miii.
Cyclophosphamide (Cytoxan) — >240 mini.
Carmustine — LiD0 Min.
Thiotepa — 8.13 mmn.
Paliltaxel (Traxol) — >240 mmn
Doxorubicin Hydrochloride — >240 nudn.
Dacarbazine (DTIC) — >240 mini.
Cisplatin — >240 min.
Ifosfamide (Ifex) — >240 min.
Miltoxantrone — >240 min.
Vincristine Sulfate — >240 mini.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K093726 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093726: Mediguard Nitrile Examination Glove- Blue (Tested for Use with Chemotherapy Drugs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093726
Report an extraction error
Are you the manufacturer?
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