510(k) · Cleared
ClearedSynthetic Powder-Free Vinyl Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shijiazhuang Great Eagle Plastic Products Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Oct 30, 1998 as substantially equivalent to K964964 (Sunmax Enterprise Shanghai Co., Ltd., 1997) and 1 other predicate after a 46-day review. Its family tree reaches back 1 generation to 1994. 8 later devices descend from it.
- Decided
- Oct 30, 1998
- Review
- 46 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942042 (1994). 2 ancestors in all. 8 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK942042 Powder Free Vinyl Patient Examination GlovesCheer & Merit Co., Ltd. · 1994
- This deviceK983207 Synthetic Powder-Free Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 1998
- Descendant · cites it directly · 2 of its ownK092296 Powder Free Examination GloveBettercare Plastic Products Co., Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK102093 Powder Free Vinyl Patient Examination GlovesShijiazhuang Great Vision Plastic Products Co., LT · 2010
- Descendant · 2 generations on · 0 of its ownK101137 Powder Free Vinyl Patient Examination GloveHongze Plastic Technology Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK093798 Powder Free Vinyl Patient Examination GloveSupermax Plastic Products Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK070037 Powder Free Vinyl Patient Examination GloveShijiazhuang Lianhe Shunda Plastic Products Co., L · 2007
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K092296Powder Free Examination GloveBettercare Plastic Products Co., Ltd. · 2009 · cites it directly2descendants
- K102093Powder Free Vinyl Patient Examination GlovesShijiazhuang Great Vision Plastic Products Co., LT · 2010 · 2 generations on0descendants
- K101137Powder Free Vinyl Patient Examination GloveHongze Plastic Technology Co., Ltd. · 2010 · 2 generations on0descendants
- K093798Powder Free Vinyl Patient Examination GloveSupermax Plastic Products Co., Ltd. · 2010 · cites it directly0descendants
- K070037Powder Free Vinyl Patient Examination GloveShijiazhuang Lianhe Shunda Plastic Products Co., L · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942042 | Powder Free Vinyl Patient Examination Gloves | Cheer & Merit Co., Ltd. | 1994 | — |
| 0 (this device) | K983207 | Synthetic Powder-Free Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 1998 | — |
| +1 | K092296 | Powder Free Examination Glove | Bettercare Plastic Products Co., Ltd. | 2009 | — |
| +2 | K102093 | Powder Free Vinyl Patient Examination Gloves | Shijiazhuang Great Vision Plastic Products Co., LT | 2010 | — |
| +2 | K101137 | Powder Free Vinyl Patient Examination Glove | Hongze Plastic Technology Co., Ltd. | 2010 | — |
| +1 | K093798 | Powder Free Vinyl Patient Examination Glove | Supermax Plastic Products Co., Ltd. | 2010 | — |
| +1 | K070037 | Powder Free Vinyl Patient Examination Glove | Shijiazhuang Lianhe Shunda Plastic Products Co., L | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 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 |
|---|---|---|---|
| * | K964964 | Powder-Free Vinyl Patient Examination GlovesSummary page 1…nthetic Powder-Free Vinyl Patient Examination Gloves Predicate Device Information: Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, K#964964 Cheer & Merit Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, K#942042 Device Description: Classified by FDA's General… | 1997 |
| * | K942042 | Powder Free Vinyl Patient Examination GlovesSummary page 1…on: Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, K#964964 Cheer & Merit Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, K#942042 Device Description: Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl… | 1994 |
What descends from it? (8)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092296 | Powder Free Examination Glove | 2009 | 2 |
| K093798 | Powder Free Vinyl Patient Examination Glove | 2010 | 0 |
| K070037 | Powder Free Vinyl Patient Examination Glove | 2007 | 0 |
| K070030 | Powder Free Vinyl Patient Examination Glove | 2007 | 0 |
| K070187 | Powder Free Vinyl Patient Examination Glove | 2007 | 0 |
| K011885 | Synthetic Powder Free Vinyl Patient Examination Gloves | 2001 | 0 |
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?
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/K983207 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983207: Synthetic Powder-Free 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/K983207
Report an extraction error
Are you the manufacturer?
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