510(k) · Cleared
ClearedPowdered Vinyl Exam Gloves, White
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glormed Intl., Inc. · LYZ Vinyl Patient Examination Glove
Cleared on Jun 10, 2003 as substantially equivalent to K021353 (Glormed Intl., Inc., 2002) after a 64-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jun 10, 2003
- Review
- 64 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992979 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK992979 Shanghai Poseidon Powder-Free Synthetic Vinyl Examination Gloves…Shanghai Poseidon Plastic Products Co., Ltd. · 2000
- 1 generation backK021353 Powder-Free-Vinyl Examination Gloves, Color: WhiteGlormed Intl., Inc. · 2002
- This deviceK031104 Powdered Vinyl Exam Gloves, WhiteGlormed Intl., Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992979 | Shanghai Poseidon Powder-Free Synthetic Vinyl Examination Gloves, Yellow | Shanghai Poseidon Plastic Products Co., Ltd. | 2000 | — |
| −1 | K021353 | Powder-Free-Vinyl Examination Gloves, Color: White | Glormed Intl., Inc. | 2002 | — |
| 0 (this device) | K031104 | Powdered Vinyl Exam Gloves, White | Glormed Intl., Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K021353 | Powder-Free-Vinyl Examination Gloves, Color: WhiteSummary page 1…y marketed by U.S. companies. Except for U.S.P. powder, it is the exact same glove manufactured in approved 5 1O(k) K021353. . 5 1Ok) Summary page 2 Test Results (Means and/or Successfbl Results: This device has met or ex… | 2002 |
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 3 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K021353.
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 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/K031104 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031104: Powdered Vinyl Exam Gloves, White.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031104
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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