510(k) · Cleared
ClearedLanfan Powder-Free Vinyl Exam Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Lanfan Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Oct 19, 2007 as substantially equivalent to K070149 (Wuxi Shenzhou Plastic Products Co., Ltd., 2007) and 1 other predicate after a 45-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Oct 19, 2007
- Review
- 45 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000071 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK000071 Synthetic Powder Free (White) Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 2000
- 2 generations backK032908 Fuguan (Brand) Powder-Free Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003
- 1 generation backK070149 Powder-Free Vinyl Patient Examination GlovesWuxi Shenzhou Plastic Products Co., Ltd. · 2007
- This deviceK072488 Lanfan Powder-Free Vinyl Exam GlovesShanghai Lanfan Co., Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000071 | Synthetic Powder Free (White) Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 2000 | — |
| −2 | K032908 | Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 2003 | — |
| −1 | K070149 | Powder-Free Vinyl Patient Examination Gloves | Wuxi Shenzhou Plastic Products Co., Ltd. | 2007 | — |
| 0 (this device) | K072488 | Lanfan Powder-Free Vinyl Exam Gloves | Shanghai Lanfan Co., Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 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? (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 |
|---|---|---|---|
| * | K070149 | Powder-Free Vinyl Patient Examination GlovesSummary page 2…for Polyvinyl Examination Gloves for Medical Application" A) K070149 POWDER-FREE VINYL Predicate Device PATIENT EXAMINATION GLOVES,… | 2007 |
| * | K052985 | Powder Free Vinyl Examination GloveSummary page 2…MANUFACTURED BY: WUXI SHENZHOU PLASTIC PRODUCTS CO., LTD. B) K052985 POWDER FREE VINYL EXAMINATION GLOVE… | 2006 |
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 7 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K070149.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Powder-free Vinyl Patient Examination Glove is disposable device made of PVC material that coated with PU coating to facilitate donning and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072488: Lanfan Powder-Free Vinyl Exam Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072488
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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