510(k) · Cleared
ClearedPowder Free Non-Sterile Vinyl Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Sunshine Plastic Products, Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Aug 12, 2010 after a 126-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Aug 12, 2010
- Review
- 126 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK100978 Powder Free Non-Sterile Vinyl Examination GloveJiangsu Sunshine Plastic Products, Co., Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK143277 Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White…Lifestyle Safety Products (Hui Zhou) Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK160675 Powder free vinyl patient examination glove, colored (yellow)Kaixing Plastic Products Co., Litd. · 2016
- Descendant · cites it directly · 0 of its ownK150934 Powder Free Vinyl Patient Examination Glove (Non?-Sterile)Lpl (Hui Zhou) Glove · 2015
- Descendant · cites it directly · 0 of its ownK112741 Powder Free Vinyl Patient Examination GloveLifestyle Safty Products (Hui Zhou) Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK111598 Powder-Free Non-Sterile Vinyl Examination GloveLpl (Hui Zhou) Glove Co., Ltd. · 2011
Most influential descendants
Showing 5 of 5 · See all- K143277Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient…Lifestyle Safety Products (Hui Zhou) Co., Ltd. · 2015 · cites it directly1descendant
- K160675Powder free vinyl patient examination glove, colored (yellow)Kaixing Plastic Products Co., Litd. · 2016 · 2 generations on0descendants
- K150934Powder Free Vinyl Patient Examination Glove (Non?-Sterile)Lpl (Hui Zhou) Glove · 2015 · cites it directly0descendants
- K112741Powder Free Vinyl Patient Examination GloveLifestyle Safty Products (Hui Zhou) Co., Ltd. · 2012 · cites it directly0descendants
- K111598Powder-Free Non-Sterile Vinyl Examination GloveLpl (Hui Zhou) Glove Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100978 | Powder Free Non-Sterile Vinyl Examination Glove | Jiangsu Sunshine Plastic Products, Co., Ltd. | 2010 | — |
| +1 | K143277 | Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl… | Lifestyle Safety Products (Hui Zhou) Co., Ltd. | 2015 | — |
| +2 | K160675 | Powder free vinyl patient examination glove, colored (yellow) | Kaixing Plastic Products Co., Litd. | 2016 | — |
| +1 | K150934 | Powder Free Vinyl Patient Examination Glove (Non?-Sterile) | Lpl (Hui Zhou) Glove | 2015 | — |
| +1 | K112741 | Powder Free Vinyl Patient Examination Glove | Lifestyle Safty Products (Hui Zhou) Co., Ltd. | 2012 | — |
| +1 | K111598 | Powder-Free Non-Sterile Vinyl Examination Glove | Lpl (Hui Zhou) Glove Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143277 | Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient… | 2015 | 1 |
| K150934 | Powder Free Vinyl Patient Examination Glove (Non?-Sterile) | 2015 | 0 |
| K112741 | Powder Free Vinyl Patient Examination Glove | 2012 | 0 |
| K111598 | Powder-Free Non-Sterile Vinyl Examination Glove | 2011 | 0 |
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?
- Of its descendants, K143277 (Lifestyle Safety Products (Hui Zhou) Co., Ltd., 2015) has gone furthest, with 1 descendant 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. 2010, 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?
The 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 examniner.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K100978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100978: Powder Free Non-Sterile Vinyl Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100978
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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