510(k) · Cleared
ClearedDisposable Powder Free Vinyl Synthetic Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safehealth Medical Supply Corp. · LYZ Vinyl Patient Examination Glove
Cleared on Dec 15, 1995 after a 38-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Dec 15, 1995
- Review
- 38 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK955091 Disposable Powder Free Vinyl Synthetic GlovesSafehealth Medical Supply Corp. · 1995
- Descendant · cites it directly · 0 of its ownK082443 Disposable Synthetic Examination Gloves, Powder FreeRich Mountain Medical Products, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK071123 Disposable Powder Free Vinyl Exam Glove, Yellow ColorXuzhou Full Sun Medical Products, Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK051393 Disposable Powder Free Vinyl Exam Glove Yellow ColorEver Global Enterprise Corporation · 2005
Most influential descendants
Showing 3 of 3 · See all- K082443Disposable Synthetic Examination Gloves, Powder FreeRich Mountain Medical Products, Inc. · 2008 · cites it directly0descendants
- K071123Disposable Powder Free Vinyl Exam Glove, Yellow ColorXuzhou Full Sun Medical Products, Ltd. · 2007 · cites it directly0descendants
- K051393Disposable Powder Free Vinyl Exam Glove Yellow ColorEver Global Enterprise Corporation · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955091 | Disposable Powder Free Vinyl Synthetic Gloves | Safehealth Medical Supply Corp. | 1995 | — |
| +1 | K082443 | Disposable Synthetic Examination Gloves, Powder Free | Rich Mountain Medical Products, Inc. | 2008 | — |
| +1 | K071123 | Disposable Powder Free Vinyl Exam Glove, Yellow Color | Xuzhou Full Sun Medical Products, Ltd. | 2007 | — |
| +1 | K051393 | Disposable Powder Free Vinyl Exam Glove Yellow Color | Ever Global Enterprise Corporation | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K082443 (Rich Mountain Medical Products, Inc., 2008) 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.
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 | — |
https://510kreport.com/device/K955091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955091: Disposable Powder Free Vinyl Synthetic Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955091
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026