510(k) · Cleared
ClearedNon-Sterile, Powder-Free, Black Nitrile Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sgmp Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Mar 27, 2008 as substantially equivalent to K000868 (Sgmp Co., Ltd., 2000) after a 213-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Mar 27, 2008
- Review
- 213 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000868 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000868 Non-Sterile Powder-Free, Blue Nitrile Examination GlovesSgmp Co., Ltd. · 2000
- This deviceK072400 Non-Sterile, Powder-Free, Black Nitrile Examination GlovesSgmp Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK101646 Non-Sterile, Powder Free Black Nitrile Examination Gloves with…Sgmp Co., Ltd. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101646Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry FlavorSgmp Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000868 | Non-Sterile Powder-Free, Blue Nitrile Examination Gloves | Sgmp Co., Ltd. | 2000 | — |
| 0 (this device) | K072400 | Non-Sterile, Powder-Free, Black Nitrile Examination Gloves | Sgmp Co., Ltd. | 2008 | — |
| +1 | K101646 | Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry Flavor | Sgmp Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K000868 | Non-Sterile Powder-Free, Blue Nitrile Examination GlovesSummary page 1…Fax No: 775-342-2613 E-mail: Tuckerjan~aol. corn Equivalent Predicate Device: POWDER FREE BLUE NITRILE EXAM GLOVES \*hich was granted a 510(k) it K000868 This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. Devic… | 2000 |
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 |
|---|---|---|---|
| K101646 | Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry Flavor | 2010 | 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?
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Non-sterile Powder Free Black Nitrile Examination Gloves, 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 summary.
https://510kreport.com/device/K072400 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072400: Non-Sterile, Powder-Free, Black Nitrile Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072400
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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