510(k) · Cleared
ClearedPowder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline · LZA Polymer Patient Examination Glove
Cleared on Aug 3, 2005 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Aug 3, 2005
- Review
- 69 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK051378 Powder-Free Blue Nitrile Examination Gloves (Tested for Use with…Medline · 2005
- Descendant · cites it directly · 2 of its ownK200960 Medline Powder Free Examination Gloves (Tested for use with…Medline Industires, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK212735 Nitrile disposable examination gloves (Tested for use with…Xingyu Medical Tech Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK212532 Disposable Powder Free Nitrile Exam Gloves (Tested For Use With…Crdlight Optoelectronic Technology Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K200960Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)Medline Industires, Inc. · 2020 · cites it directly2descendants
- K212735Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)Xingyu Medical Tech Co., Ltd. · 2022 · 2 generations on0descendants
- K212532Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)Crdlight Optoelectronic Technology Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051378 | Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy… | Medline | 2005 | — |
| +1 | K200960 | Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) | Medline Industires, Inc. | 2020 | — |
| +2 | K212735 | Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) | Xingyu Medical Tech Co., Ltd. | 2022 | — |
| +2 | K212532 | Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy… | Crdlight Optoelectronic Technology Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200960 | Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) | 2020 | 2 |
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, K200960 (Medline Industires, Inc., 2020) has gone furthest, with 2 descendants 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.
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?
Medline Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) 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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051378: Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051378
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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