510(k) · Cleared
ClearedPowder-Free Vinyl Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Super Gloves Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Dec 17, 1997 as substantially equivalent to K964964 (Sunmax Enterprise Shanghai Co., Ltd., 1997) and 1 other predicate after a 47-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.
- Decided
- Dec 17, 1997
- Review
- 47 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. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK942042 Powder Free Vinyl Patient Examination GlovesCheer & Merit Co., Ltd. · 1994
- This deviceK974120 Powder-Free Vinyl Patient Examination GlovesShanghai Super Gloves Co., Ltd. · 1997
- Descendant · cites it directly · 2 of its ownK984460 Powder-Free Vinyl Patient Examination GlovesShanghai Huamao Gloves Co., Ltd. · 1999
- Descendant · 2 generations on · 0 of its ownK993880 Shanghai Glovmax Enterprise CO, LTD., Powder-Free Vinyl Patient…Shanghai Glovmax Enterprise Co.,Ltd · 2000
- Descendant · cites it directly · 0 of its ownK992272 Powder-Free Vinyl Patient Examination GlovesShanghai Cosmos Corp. · 1999
- Descendant · 2 generations on · 0 of its ownK992206 Powder-Free Vinyl Patient Examination GlovesShanghai China Star Corp · 1999
Most influential descendants
Showing 4 of 4 · See all- K984460Powder-Free Vinyl Patient Examination GlovesShanghai Huamao Gloves Co., Ltd. · 1999 · cites it directly2descendants
- K993880Shanghai Glovmax Enterprise CO, LTD., Powder-Free Vinyl Patient Examination GlovesShanghai Glovmax Enterprise Co.,Ltd · 2000 · 2 generations on0descendants
- K992272Powder-Free Vinyl Patient Examination GlovesShanghai Cosmos Corp. · 1999 · cites it directly0descendants
- K992206Powder-Free Vinyl Patient Examination GlovesShanghai China Star Corp · 1999 · 2 generations on0descendants
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) | K974120 | Powder-Free Vinyl Patient Examination Gloves | Shanghai Super Gloves Co., Ltd. | 1997 | — |
| +1 | K984460 | Powder-Free Vinyl Patient Examination Gloves | Shanghai Huamao Gloves Co., Ltd. | 1999 | — |
| +2 | K993880 | Shanghai Glovmax Enterprise CO, LTD., Powder-Free Vinyl Patient Examination… | Shanghai Glovmax Enterprise Co.,Ltd | 2000 | — |
| +1 | K992272 | Powder-Free Vinyl Patient Examination Gloves | Shanghai Cosmos Corp. | 1999 | — |
| +2 | K992206 | Powder-Free Vinyl Patient Examination Gloves | Shanghai China Star Corp | 1999 | — |
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 |
|---|---|---|
| 1999 | 3 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K964964 | Powder-Free Vinyl Patient Examination GlovesSummary page 1…., Ltd. 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? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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/K974120 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974120: 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/K974120
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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