510(k) · Cleared
ClearedGlide-On Vinyl Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · LYZ Vinyl Patient Examination Glove
Cleared on Mar 22, 2016 as substantially equivalent to K142703 (Hebei Grandeast Plastic Products Co., Ltd., 2015) after a 267-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Mar 22, 2016
- Review
- 267 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000071 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backK000071 Synthetic Powder Free (White) Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 2000
- 4 generations backK032908 Fuguan (Brand) Powder-Free Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003
- 3 generations backK120968 Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Tangshan Zhonghong Pulin Plastic Co.,Ltd · 2012 · Recalled
- 2 generations backK130733 Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Benteng Plastic Co., Ltd. · 2014
- 1 generation backK142703 Powder-free PVC Vinyl Exam GlovesHebei Grandeast Plastic Products Co., Ltd. · 2015
- This deviceK151754 Glide-On Vinyl Examination GlovesMedline Industries, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000071 | Synthetic Powder Free (White) Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 2000 | — |
| −4 | K032908 | Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 2003 | — |
| −3 | K120968 | Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Tangshan Zhonghong Pulin Plastic Co.,Ltd | 2012 | 1 |
| −2 | K130733 | Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Benteng Plastic Co., Ltd. | 2014 | — |
| −1 | K142703 | Powder-free PVC Vinyl Exam Gloves | Hebei Grandeast Plastic Products Co., Ltd. | 2015 | — |
| 0 (this device) | K151754 | Glide-On Vinyl Examination Gloves | Medline Industries, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K142703 | Powder-free PVC Vinyl Exam GlovesSummary page 4…lass: Class I Regulation #: 21 CFR 880.6250 Classification Panel: General Hospital Predicate Device Powder-Free PVC Vinyl Patient Examination Glove, Clear (non-colored) K142703 Device Description The Glide-On Vinyl Examination Gloves are single use only, disposable gloves intended for medical purposes to… | 2015 |
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 16 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 3 other devices also cite its predicate K142703.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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?
The Glide-On Vinyl Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151754: Glide-On Vinyl Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151754
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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