510(k) · Cleared
ClearedPowder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Benteng Plastic Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jun 18, 2014 as substantially equivalent to K120968 (Tangshan Zhonghong Pulin Plastic Co.,Ltd, 2012) after a 457-day review. Its family tree reaches back 3 generations to 2000. 5 later devices descend from it.
- Decided
- Jun 18, 2014
- Review
- 457 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000071 (2000). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK000071 Synthetic Powder Free (White) Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 2000
- 2 generations backK032908 Fuguan (Brand) Powder-Free Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003
- 1 generation backK120968 Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Tangshan Zhonghong Pulin Plastic Co.,Ltd · 2012 · Recalled
- This deviceK130733 Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Benteng Plastic Co., Ltd. · 2014
- Descendant · cites it directly · 4 of its ownK142703 Powder-free PVC Vinyl Exam GlovesHebei Grandeast Plastic Products Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK173078 Powder-free Clear Vinyl Patient Examination GlovesYongsheng Medical Products Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK171317 Clear Vinyl Powder-free Patient Examination GlovesShandong Zhi Hong Medical Products, Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK170735 Powder-Free Clear Vinyl Patient Examination GlovesZibo Yue Fan Medical Products Co, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK151754 Glide-On Vinyl Examination GlovesMedline Industries, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K142703Powder-free PVC Vinyl Exam GlovesHebei Grandeast Plastic Products Co., Ltd. · 2015 · cites it directly4descendants
- K173078Powder-free Clear Vinyl Patient Examination GlovesYongsheng Medical Products Co., Ltd. · 2018 · 2 generations on0descendants
- K171317Clear Vinyl Powder-free Patient Examination GlovesShandong Zhi Hong Medical Products, Co., Ltd. · 2017 · 2 generations on0descendants
- K170735Powder-Free Clear Vinyl Patient Examination GlovesZibo Yue Fan Medical Products Co, Ltd. · 2017 · 2 generations on0descendants
- K151754Glide-On Vinyl Examination GlovesMedline Industries, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000071 | Synthetic Powder Free (White) Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 2000 | — |
| −2 | K032908 | Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 2003 | — |
| −1 | K120968 | Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Tangshan Zhonghong Pulin Plastic Co.,Ltd | 2012 | 1 |
| 0 (this device) | 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 | — |
| +2 | K173078 | Powder-free Clear Vinyl Patient Examination Gloves | Yongsheng Medical Products Co., Ltd. | 2018 | — |
| +2 | K171317 | Clear Vinyl Powder-free Patient Examination Gloves | Shandong Zhi Hong Medical Products, Co., Ltd. | 2017 | — |
| +2 | K170735 | Powder-Free Clear Vinyl Patient Examination Gloves | Zibo Yue Fan Medical Products Co, Ltd. | 2017 | — |
| +2 | K151754 | Glide-On Vinyl Examination Gloves | Medline Industries, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K120968 | Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Summary page 1…standard D 5250-06 (Reaffirmation 2011). Predicate device : Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd. K 120968 . Section C(rev.03) Page 1/4 [(a)(4)j… | 2012 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142703 | Powder-free PVC Vinyl Exam Gloves | 2015 | 4 |
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 14 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K142703 (Hebei Grandeast Plastic Products Co., Ltd., 2015) has gone furthest, with 4 descendants of its own.
- 13 other devices also cite its predicate K120968.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examinees hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130733 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130733: Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130733
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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