510(k) · Cleared
ClearedVinyl Exam Gloves, Powder Free, Clear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zibo Hongchin Plastic and Rubber Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Dec 19, 2016 as substantially equivalent to K022091 (Tangshan Zhonghong Pulin Group Co., Ltd., 2002) after a 214-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Dec 19, 2016
- Review
- 214 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022091 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK022091 Baldur Brand Vinyl Powder-Free Examination GlovesTangshan Zhonghong Pulin Group Co., Ltd. · 2002
- This deviceK161390 Vinyl Exam Gloves, Powder Free, ClearZibo Hongchin Plastic and Rubber Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022091 | Baldur Brand Vinyl Powder-Free Examination Gloves | Tangshan Zhonghong Pulin Group Co., Ltd. | 2002 | — |
| 0 (this device) | K161390 | Vinyl Exam Gloves, Powder Free, Clear | Zibo Hongchin Plastic and Rubber Co., Ltd. | 2016 | — |
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 LYZ? 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 LYZ device
- #1 K260860 Powder Free Synthetic Vinyl Exam Gloves (Blue…score 11.4 · 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 |
|---|---|---|---|
| * | K022091 | Baldur Brand Vinyl Powder-Free Examination GlovesSummary page 4…Co.,Ltd No 17 Yingxiong Rd, Zhangdian District, Zibo Shandong, 255400 China Predicate Device Information: Device name: Vinyl Examination Gloves Powder-Free 510(K) #: K022091 Manufacturer name: Tangshan Zhonghong Pulin Food Products Co., Ltd Device Description: Subject device: Vinyl Exam Gloves, Powd… | 2002 |
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?
- Its one ancestor has no recall.
- 8 other devices also cite its predicate K022091.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LYZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYZ
100in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYZ
2in 2025
MAUDE reports naming product code LYZ, 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 | 36 | 47 | 0 | 4 |
| 2008 | 18 | 90 | 0 | 0 |
| 2009 | 49 | 71 | 1 | 0 |
| 2010 | 72 | 66 | 0 | 2 |
| 2011 | 33 | 86 | 3 | 5 |
| 2012 | 25 | 84 | 1 | 5 |
| 2013 | 8 | 193 | 0 | 2 |
| 2014 | 40 | 226 | 0 | 6 |
| 2015 | 14 | 180 | 0 | 1 |
| 2016 | 11 | 145 | 1 | 11 |
| 2017 | 9 | 109 | 0 | 6 |
| 2018 | 10 | 80 | 0 | 0 |
| 2019 | 4 | 162 | 0 | 3 |
| 2020 | 4 | 85 | 0 | 1 |
| 2021 | 30 | 91 | 0 | 4 |
| 2022 | 10 | 100 | 0 | 1 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner’s hands or fingers to prevent contamination between patient and examiner
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/K161390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161390: Vinyl Exam Gloves, Powder Free, Clear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161390
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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