510(k) · Cleared
ClearedVinyl Patient Examination Glove, Powdered
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 Oct 15, 1998 after a 184-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Oct 15, 1998
- Review
- 184 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK981360 Vinyl Patient Examination Glove, PowderedGlormed Intl., Inc. · 1998
- Descendant · cites it directly · 2 of its ownK983494 Vinyl Exam Gloves, Powder FreeGlormed Intl., Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK091471 Patient Examination Gloves, Powder-Free VinylCartagloves S.A. · 2009
- Descendant · 2 generations on · 0 of its ownK071022 Powder-Free Vinyl Examination GlovesGlormed Colombia S.A. · 2007
Most influential descendants
Showing 3 of 3 · See all- K983494Vinyl Exam Gloves, Powder FreeGlormed Intl., Inc. · 1998 · cites it directly2descendants
- K091471Patient Examination Gloves, Powder-Free VinylCartagloves S.A. · 2009 · 2 generations on0descendants
- K071022Powder-Free Vinyl Examination GlovesGlormed Colombia S.A. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981360 | Vinyl Patient Examination Glove, Powdered | Glormed Intl., Inc. | 1998 | — |
| +1 | K983494 | Vinyl Exam Gloves, Powder Free | Glormed Intl., Inc. | 1998 | — |
| +2 | K091471 | Patient Examination Gloves, Powder-Free Vinyl | Cartagloves S.A. | 2009 | — |
| +2 | K071022 | Powder-Free Vinyl Examination Gloves | Glormed Colombia S.A. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983494 | Vinyl Exam Gloves, Powder Free | 1998 | 2 |
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, K983494 (Glormed Intl., Inc., 1998) has gone furthest, with 2 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 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981360 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981360: Vinyl Patient Examination Glove, Powdered.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981360
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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