510(k) · Cleared
ClearedPowder-Free Nitrile Exam Gloves, Color: Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ningbo Tianshun Rubber Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Dec 18, 2002 as substantially equivalent to K011286 (Ningbo Yujiang Plastic & Rubber Co., Ltd., 2001) and 1 other predicate after a 47-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Dec 18, 2002
- Review
- 47 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000670 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK000670 Nitrile Exam Glove, Powder Free, BlueShasta Asia Partners Gloves Manufacturing CO, Ltd. · 2000
- This deviceK023702 Powder-Free Nitrile Exam Gloves, Color: BlueNingbo Tianshun Rubber Products Co., Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000670 | Nitrile Exam Glove, Powder Free, Blue | Shasta Asia Partners Gloves Manufacturing CO, Ltd. | 2000 | — |
| 0 (this device) | K023702 | Powder-Free Nitrile Exam Gloves, Color: Blue | Ningbo Tianshun Rubber Products Co., Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K011286 | Powder-Free Nitrile Exam Glove, BlueSummary page 1…companies. It is Substantially Equivalent to the gloves manufactured by Ningbo Yujiang Plastic & Rubber Co., Ltd. (K011286) and Shasta Asia Partners Gloves Mfg Co., Ltd. (K000670). 5 1Ok) Summary page 2. Test… | 2001 |
| * | K000670 | Nitrile Exam Glove, Powder Free, BlueSummary page 1…manufactured by Ningbo Yujiang Plastic & Rubber Co., Ltd. (K011286) and Shasta Asia Partners Gloves Mfg Co., Ltd. (K000670). 5 1Ok) Summary page 2. Test Results (Means and/or Successfbl Results: This device has met or e… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
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?
A 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023702: Powder-Free Nitrile Exam Gloves, Color: Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023702
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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