510(k) · Cleared
ClearedSynmax Synthetic Examination Vinyl Gloves, Powder Free, Blue Color
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zibo Intco Medical Products Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Nov 27, 2013 as substantially equivalent to K011882 (Shijiazhuang Eversharp Plastic Products Co., Ltd., 2001) after a 134-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Nov 27, 2013
- Review
- 134 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992861 (1999). No later device cites it as a predicate yet.
- Root · 2 generations backK992861 Synthetic Powder Free (Yellow) Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 1999
- 1 generation backK011882 Synthetic Powder Free (Yellow) Vinyl Patient Examination GlovesShijiazhuang Eversharp Plastic Products Co., Ltd. · 2001
- This deviceK132201 Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue ColorZibo Intco Medical Products Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992861 | Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 1999 | — |
| −1 | K011882 | Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001 | — |
| 0 (this device) | K132201 | Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue Color | Zibo Intco Medical Products Co., Ltd. | 2013 | — |
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 |
|---|---|---|---|
| * | K011882 | Synthetic Powder Free (Yellow) Vinyl Patient Examination GlovesSummary page 4…ect device) and Shijiazhuang Eversbarp Plastic Products Co., LId.Synthetic Powder Free (Yellow) Vinyl Examination Gloves (KO011882) (predicate device) are substantially equivalent in all technological characteistics, including… | 2001 |
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 14 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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.(21 CFR 880.6250)
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/K132201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132201: Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132201
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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