510(k) · Cleared
ClearedVinyl Exam Gloves, Powder Free
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 Nov 5, 1998 as substantially equivalent to K981360 (Glormed Intl., Inc., 1998) after a 31-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Nov 5, 1998
- Review
- 31 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981360 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK981360 Vinyl Patient Examination Glove, PowderedGlormed Intl., Inc. · 1998
- This deviceK983494 Vinyl Exam Gloves, Powder FreeGlormed Intl., Inc. · 1998
- Descendant · cites it directly · 0 of its ownK091471 Patient Examination Gloves, Powder-Free VinylCartagloves S.A. · 2009
- Descendant · cites it directly · 0 of its ownK071022 Powder-Free Vinyl Examination GlovesGlormed Colombia S.A. · 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 |
|---|---|---|---|---|---|
| −1 | K981360 | Vinyl Patient Examination Glove, Powdered | Glormed Intl., Inc. | 1998 | — |
| 0 (this device) | K983494 | Vinyl Exam Gloves, Powder Free | Glormed Intl., Inc. | 1998 | — |
| +1 | K091471 | Patient Examination Gloves, Powder-Free Vinyl | Cartagloves S.A. | 2009 | — |
| +1 | K071022 | Powder-Free Vinyl Examination Gloves | Glormed Colombia S.A. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K981360 | Vinyl Patient Examination Glove, Powdered Cleared while this submission was under review Summary page 1…equivalence summary to anyone requesting it from the preparer. NEW DEVICE NAME: VINYL EXAMINATION GLOVE, POWDER-FREE PREDICATE DEVICE NAME: Vinyl Exam Glove, Powdered, K981360, everything is the same process except for adding powder to finished glove. The device is powder-free vinyl exam gloves. They ar… | 1998 |
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?
- Its one ancestor has no recall.
- Of its descendants, K091471 (Cartagloves S.A., 2009) 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 purposes that is
worn on the examiner’s hand or finger to prevent contamination between patient and
examiner.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983494 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983494: Vinyl Exam Gloves, Powder Free.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983494
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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