510(k) · Cleared
ClearedPowdered Vinyl Patient Examination Gloves, Clear (Non-Colored)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shijiazhuang Sail Plastic Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jul 16, 2010 as substantially equivalent to K032907 (Shijiazhuang Fuguan Plastic Products Co., Ltd., 2003) after a 15-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- Jul 16, 2010
- Review
- 15 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K893822 (1989). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK893822 Honyee Vinyl Examination GlovesHonyee Enterprise Co. · 1989
- 5 generations backK960746 Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. GlovesSunmax Enterprise Shanghai Co., Ltd. · 1996
- 4 generations backK974151 Vinyl Patient Examination Gloves (Powdered)Shanghai Super Gloves Co., Ltd. · 1997
- 3 generations backK983645 Synthetic Powdered Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 1998
- 2 generations backK011884 Powdered Synthetic Vinyl Patient Examination GlovesShijiazhuang Eversharp Plastic Products Co., Ltd. · 2001
- 1 generation backK032907 Fuguan (Brand) Powdered Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003
- This deviceK101841 Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored)Shijiazhuang Sail Plastic Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K893822 | Honyee Vinyl Examination Gloves | Honyee Enterprise Co. | 1989 | — |
| −5 | K960746 | Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves | Sunmax Enterprise Shanghai Co., Ltd. | 1996 | — |
| −4 | K974151 | Vinyl Patient Examination Gloves (Powdered) | Shanghai Super Gloves Co., Ltd. | 1997 | — |
| −3 | K983645 | Synthetic Powdered Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 1998 | — |
| −2 | K011884 | Powdered Synthetic Vinyl Patient Examination Gloves | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001 | — |
| −1 | K032907 | Fuguan (Brand) Powdered Vinyl Patient Examination Gloves | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 2003 | — |
| 0 (this device) | K101841 | Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored) | Shijiazhuang Sail Plastic Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K032907 | Fuguan (Brand) Powdered Vinyl Patient Examination GlovesSummary page 1…requirements of ASTM standard D 5250-06. Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K(032907. [(a) (4)J A description of the device Device Description :powdered vinyl patient examination gloves, Clear(non… | 2003 |
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 21 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- None of the 7 ancestors has a recall.
- 28 other devices also cite its predicate K032907.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Powdered vinyl 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/K101841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101841: Powdered 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/K101841
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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