510(k) · Cleared
ClearedDisposable Powder Free Vinyl Synthetic Examination Glove, White Color
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mdm Enterprise Corp. · LYZ Vinyl Patient Examination Glove
Cleared on Jan 22, 2004 after a 43-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Jan 22, 2004
- Review
- 43 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK033835 Disposable Powder Free Vinyl Synthetic Examination Glove, White ColorMdm Enterprise Corp. · 2004
- Descendant · cites it directly · 0 of its ownK081535 Disposable Powder Free Vinyl Synthetic Exam Gloves, White ColorRich Mountain Medical Products, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK072377 Disposable Powder Free Vinyl Synthetic Exam Glove, White ColorXuzhou Full Sun Medical Products, Ltd. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033835 | Disposable Powder Free Vinyl Synthetic Examination Glove, White Color | Mdm Enterprise Corp. | 2004 | — |
| +1 | K081535 | Disposable Powder Free Vinyl Synthetic Exam Gloves, White Color | Rich Mountain Medical Products, Inc. | 2008 | — |
| +1 | K072377 | Disposable Powder Free Vinyl Synthetic Exam Glove, White Color | Xuzhou Full Sun Medical Products, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 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?
The FDA summary names no predicate by number.
What descends from it? (2)
2 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, K081535 (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 | — |
What is it indicated for?
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between the patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033835: Disposable Powder Free Vinyl Synthetic Examination Glove, White Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033835
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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