510(k) · Cleared
Recalled · 2011Powder Free Vinyl Patient Examination Gloves (Light Yellow)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Cureguard Glove Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jul 21, 2008 as substantially equivalent to K070076 (Jiangsu Cureguard Glove Co., Ltd., 2007) after a 39-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jul 21, 2008
- Review
- 39 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070076 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK070076 Powder Free Vinyl Patinet Examination Gloves, Clear (Non-Colored)Jiangsu Cureguard Glove Co., Ltd. · 2007
- This deviceK081655 Powder Free Vinyl Patient Examination Gloves (Light Yellow)Jiangsu Cureguard Glove Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK093576 Rubber-Like Powder Free Vinyl Patient Examination Gloves, White ColorJiangsu Cureguard Glove Co., Ltd. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093576Rubber-Like Powder Free Vinyl Patient Examination Gloves, White ColorJiangsu Cureguard Glove Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070076 | Powder Free Vinyl Patinet Examination Gloves, Clear (Non-Colored) | Jiangsu Cureguard Glove Co., Ltd. | 2007 | — |
| 0 (this device) | K081655 | Powder Free Vinyl Patient Examination Gloves (Light Yellow) | Jiangsu Cureguard Glove Co., Ltd. | 2008 | — |
| +1 | K093576 | Rubber-Like Powder Free Vinyl Patient Examination Gloves, White Color | Jiangsu Cureguard Glove Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (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 |
|---|---|---|---|
| * | K070076 | Powder Free Vinyl Patinet Examination Gloves, Clear (Non-Colored)Summary page 1…ellow) that meets all of the requirements of ASTM standard D 5250-06. Predicate device: Powder-Free Vinyl Patient Examination Gloves, JIANGSU CUREGUARD GLOVE CO., LTD.. K070076 1(a)(4)] A description of the device Device Description: powder free vinyl patient examination gloves, (Light Y… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093576 | Rubber-Like Powder Free Vinyl Patient Examination Gloves, White Color | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2011 | Not classified | Z-1554-2011 | Release of Material/Component prior to receiving test results | The recall was initiated because the affected lot, lot number JCU004958569, of gloves did not meet the requirements for the water-leak test. |
| Feb 3, 2011 | Not classified | Z-1553-2011 | Release of Material/Component prior to receiving test results | The recall was initiated because the affected lot, lot number JCU004958569, of gloves did not meet the requirements for the water-leak test. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K093576 (Jiangsu Cureguard Glove Co., Ltd., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Powder free vinyl 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/K081655 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081655: Powder Free Vinyl Patient Examination Gloves (Light Yellow).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081655
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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