510(k) · Cleared
ClearedSynthetic Vinyl Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yunnan Huazhiyuan Medical Technology Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Sep 23, 2021 as substantially equivalent to K153028 (Zibo Huiying Medical Products, Co., Ltd., 2016) after an 87-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Sep 23, 2021
- Review
- 87 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051662 (2005). No later device cites it as a predicate yet.
- Root · 2 generations backK051662 Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color)Grand Work Plastic Products Co., Ltd. · 2005
- 1 generation backK153028 Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, BlueZibo Huiying Medical Products, Co., Ltd. · 2016
- This deviceK212002 Synthetic Vinyl Examination GlovesYunnan Huazhiyuan Medical Technology Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051662 | Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color) | Grand Work Plastic Products Co., Ltd. | 2005 | — |
| −1 | K153028 | Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue | Zibo Huiying Medical Products, Co., Ltd. | 2016 | — |
| 0 (this device) | K212002 | Synthetic Vinyl Examination Gloves | Yunnan Huazhiyuan Medical Technology Co., Ltd. | 2021 | — |
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 |
|---|---|---|---|
| * | K153028 | Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, BlueSummary page 5…1 of page 6 Synthetic Vinyl Examination Glove FDA 510(k) Files Free,Blue 510(k) number: K153028 5.0 Indication for Use A patient examination glove is a disposable device intended for medical purposes that is… | 2016 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- None of the 2 ancestors has a recall.
- 8 other devices also cite its predicate K153028.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 as stated in the FDA summary.
https://510kreport.com/device/K212002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212002: Synthetic Vinyl Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212002
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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