510(k) · Cleared
ClearedPre-Powdered Vinyl Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai China Star Corp · LYZ Vinyl Patient Examination Glove
Cleared on Jul 23, 1999 as substantially equivalent to K984461 (Shanghai Huamao Gloves Co., Ltd., 1999) after a 23-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Jul 23, 1999
- Review
- 23 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K893822 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK893822 Honyee Vinyl Examination GlovesHonyee Enterprise Co. · 1989
- 3 generations backK960746 Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. GlovesSunmax Enterprise Shanghai Co., Ltd. · 1996
- 2 generations backK974151 Vinyl Patient Examination Gloves (Powdered)Shanghai Super Gloves Co., Ltd. · 1997
- 1 generation backK984461 Pre-Powder Vinyl Patient Examination GlovesShanghai Huamao Gloves Co., Ltd. · 1999
- This deviceK992205 Pre-Powdered Vinyl Patient Examination GlovesShanghai China Star Corp · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K893822 | Honyee Vinyl Examination Gloves | Honyee Enterprise Co. | 1989 | — |
| −3 | K960746 | Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves | Sunmax Enterprise Shanghai Co., Ltd. | 1996 | — |
| −2 | K974151 | Vinyl Patient Examination Gloves (Powdered) | Shanghai Super Gloves Co., Ltd. | 1997 | — |
| −1 | K984461 | Pre-Powder Vinyl Patient Examination Gloves | Shanghai Huamao Gloves Co., Ltd. | 1999 | — |
| 0 (this device) | K992205 | Pre-Powdered Vinyl Patient Examination Gloves | Shanghai China Star Corp | 1999 | — |
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? (2)
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 |
|---|---|---|---|
| * | K984461 | Pre-Powder Vinyl Patient Examination GlovesSummary page 1…red: 25 May 1999 2.Name of the Device: SHANGHAI CHINASTAR CORP. Pre-powdered Vinyl Examination Gloves 3.Predicate Device Information: Shanghai Huamao Gloves Co., Ltd. #K984461 4.Device Description: Classified by FDA’s General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Pre-powder Vinyl… | 1999 |
| * | — | Shanghai Super Gloves Co., Ltd. Pre-powdered vinyl patient examination Gloves Named without a submission number |
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 10 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K984461.
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/K992205 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992205: Pre-Powdered Vinyl Patient Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992205
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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