510(k) · Cleared

Recalled · 2009

Synthetic Powder-Free Vinyl Patient Examination Gloves

K992821510(k) TraditionalCleared Mar 10, 2000203-day reviewClass I21 CFR 880.6250Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Shijiazhuang Hongxiang Plastics Products Co., Ltd. · LYZ Vinyl Patient Examination Glove

Cleared on Mar 10, 2000 as substantially equivalent to K964964 (Sunmax Enterprise Shanghai Co., Ltd., 1997) and 1 other predicate after a 203-day review. Its family tree reaches back 1 generation to 1994. 18 later devices descend from it. It has been recalled once.

Decided: Mar 10, 2000
Review: 203 days
Class: Class I
Product code: LYZ
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K942042 (1994). 2 ancestors in all. 18 later devices descend from it, 18 citing it directly.

By dateBy generation

Root · 1 generation backK942042 Powder Free Vinyl Patient Examination GlovesCheer & Merit Co., Ltd. · 1994
This deviceK992821 Synthetic Powder-Free Vinyl Patient Examination GlovesShijiazhuang Hongxiang Plastics Products Co., Ltd. · 2000
Descendant · cites it directly · 0 of its ownK143340 Powder Free Vinyl Patient Examination Gloves, Yellow ColorZibo Ling Yun Medical Products Co, Ltd. · 2015
Descendant · cites it directly · 0 of its ownK140322 White Vinyl Exam Gloves Powder FreeShandong Dawei Medical Products Co., Ltd. · 2014
Descendant · cites it directly · 0 of its ownK122656 Powder-Free Vinyl Patient Examination Gloves, Yellow ColorShandong Yifan Plastic Products Co., Ltd. · 2014
Descendant · cites it directly · 0 of its ownK132637 Powder-Free Vinyl Patient Examination Gloves, Yellow ColorZibo Intco Medical Products Co., Ltd. · 2014
Descendant · cites it directly · 0 of its ownK123590 Vinyl Examination Powder Free Gloves, ClearWeilin Plastic and Rubber Products Co., Ltd. · 2013

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2009high 7 (2009) · low 0 (2016)2026

Most influential descendants

Showing 5 of 18 · See all

K143340Powder Free Vinyl Patient Examination Gloves, Yellow ColorZibo Ling Yun Medical Products Co, Ltd. · 2015 · cites it directly0descendants
K140322White Vinyl Exam Gloves Powder FreeShandong Dawei Medical Products Co., Ltd. · 2014 · cites it directly0descendants
K122656Powder-Free Vinyl Patient Examination Gloves, Yellow ColorShandong Yifan Plastic Products Co., Ltd. · 2014 · cites it directly0descendants
K132637Powder-Free Vinyl Patient Examination Gloves, Yellow ColorZibo Intco Medical Products Co., Ltd. · 2014 · cites it directly0descendants
K123590Vinyl Examination Powder Free Gloves, ClearWeilin Plastic and Rubber Products Co., Ltd. · 2013 · 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)	K992821	Synthetic Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Hongxiang Plastics Products Co., Ltd.	2000	—
+1	K143340	Powder Free Vinyl Patient Examination Gloves, Yellow Color	Zibo Ling Yun Medical Products Co, Ltd.	2015	—
+1	K140322	White Vinyl Exam Gloves Powder Free	Shandong Dawei Medical Products Co., Ltd.	2014	—
+1	K122656	Powder-Free Vinyl Patient Examination Gloves, Yellow Color	Shandong Yifan Plastic Products Co., Ltd.	2014	—
+1	K132637	Powder-Free Vinyl Patient Examination Gloves, Yellow Color	Zibo Intco Medical Products Co., Ltd.	2014	—
+1	K123590	Vinyl Examination Powder Free Gloves, Clear	Weilin Plastic and Rubber Products Co., Ltd.	2013	—

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
2009	7	0
2010	3	0
2011	2	0
2012	1	0
2013	1	0
2014	3	0
2015	1	0

FIG. 1 — Lineage of K992821, 1994–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K964964	Powder-Free Vinyl Patient Examination Gloves Summary page 1 …etic 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…	Sunmax Enterprise Shanghai Co., Ltd.	1997	—
*	K942042	Powder Free Vinyl Patient Examination Gloves Summary page 1 …n: 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…	Cheer & Merit Co., Ltd.	1994	—

Also cleared against K964964: 4 other devices →

What descends from it? (18)

See all 18

18 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided
K143340	Powder Free Vinyl Patient Examination Gloves, Yellow Color	Zibo Ling Yun Medical Products Co, Ltd.	2015
K140322	White Vinyl Exam Gloves Powder Free	Shandong Dawei Medical Products Co., Ltd.	2014
K122656	Powder-Free Vinyl Patient Examination Gloves, Yellow Color	Shandong Yifan Plastic Products Co., Ltd.	2014
K132637	Powder-Free Vinyl Patient Examination Gloves, Yellow Color	Zibo Intco Medical Products Co., Ltd.	2014
K123590	Vinyl Examination Powder Free Gloves, Clear	Weilin Plastic and Rubber Products Co., Ltd.	2013
K112266	Powder-Free Vinyl Patient Examination Gloves, Yellow Color	Shandong Zhiyuan Medical Products Co., Ltd.	2012
K110857	Powder-Free Vinyl Patient Examination Gloves, Yellow Color	Shandong Zhanpeng Medical Products Co., Ltd.	2011
K110338	Powder-Free Vinyl Patient Examination Gloves	Zibo Yuechuan Plastic Products Co., Ltd.	2011
K102724	Powder-Free Vinyl Patient Examination Gloves	Zibo Yuqun New Material Science and Technology CO	2010
K102444	Powder-Free Vinyl Patient Examination Gloves	Zibo Yingbo Medical Products, Inc.	2010

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 30, 2009	Not classified	Z-1645-2009	Release of Material/Component prior to receiving test results	The product may contain defects/holes reducing the product's effectiveness as a barrier.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K143340 (Zibo Ling Yun Medical Products Co, Ltd., 2015) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K964964.

How does its category compare?

All LYZ devices

LYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYZ

2in 2025

2007high 72 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYZ

100in 2022

2007high 226 (2014) · low 47 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LYZ

1in 2016

2007high 3 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYZ

2in 2025

2007high 11 (2016) · low 0 (2008)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 disposable device intended for medical a purpose that is wom 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/K992821 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992821: Synthetic Powder-Free Vinyl Patient Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992821

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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