510(k) · Cleared

Cleared

Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves

K032908510(k) TraditionalCleared Nov 20, 200364-day reviewClass I21 CFR 880.6250

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

Shijiazhuang Fuguan Plastic Products Co., Ltd. · LYZ Vinyl Patient Examination Glove

Cleared on Nov 20, 2003 as substantially equivalent to K000071 (Shijiazhuang Great Eagle Plastic Products Co., Ltd., 2000) after a 64-day review. Its family tree reaches back 1 generation to 2000. 130 later devices descend from it.

Decided: Nov 20, 2003
Review: 64 days
Class: Class I
Product code: LYZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000071 (2000). 130 later devices descend from it, 75 citing it directly.

By dateBy generation

Root · 1 generation backK000071 Synthetic Powder Free (White) Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 2000
This deviceK032908 Fuguan (Brand) Powder-Free Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003
Descendant · cites it directly · 20 of its ownK091663 Powder-Free Vinyl Patient Examination GlovesZhangjiagang Fengyuan Plastic Products Co., Ltd. · 2009
Descendant · cites it directly · 19 of its ownK120968 Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Tangshan Zhonghong Pulin Plastic Co.,Ltd · 2012 · Recalled
Descendant · cites it directly · 9 of its ownK100699 Powder-Free Vinyl Patient Examination GlovesShijiazhuang Star Plastic Co., Ltd. · 2010
Descendant · 2 generations on · 5 of its ownK130733 Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Benteng Plastic Co., Ltd. · 2014
Descendant · 3 generations on · 4 of its ownK142703 Powder-free PVC Vinyl Exam GlovesHebei Grandeast Plastic Products Co., Ltd. · 2015

Showing 5 of 130 descendants. See all descendants

Descendants cleared per year

2005high 26 (2014) · low 0 (2020)2026

Most influential descendants

Showing 5 of 130 · See all

K091663Powder-Free Vinyl Patient Examination GlovesZhangjiagang Fengyuan Plastic Products Co., Ltd. · 2009 · cites it directly20descendants
K120968Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Tangshan Zhonghong Pulin Plastic Co.,Ltd · 2012 · cites it directly19descendants
K100699Powder-Free Vinyl Patient Examination GlovesShijiazhuang Star Plastic Co., Ltd. · 2010 · cites it directly9descendants
K130733Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Benteng Plastic Co., Ltd. · 2014 · 2 generations on5descendants
K142703Powder-free PVC Vinyl Exam GlovesHebei Grandeast Plastic Products Co., Ltd. · 2015 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000071	Synthetic Powder Free (White) Vinyl Patient Examination Gloves	Shijiazhuang Great Eagle Plastic Products Co., Ltd.	2000	—
0 (this device)	K032908	Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Fuguan Plastic Products Co., Ltd.	2003	—
+1	K091663	Powder-Free Vinyl Patient Examination Gloves	Zhangjiagang Fengyuan Plastic Products Co., Ltd.	2009	—
+1	K120968	Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Tangshan Zhonghong Pulin Plastic Co.,Ltd	2012	1
+1	K100699	Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Star Plastic Co., Ltd.	2010	—
+2	K130733	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Benteng Plastic Co., Ltd.	2014	—
+3	K142703	Powder-free PVC Vinyl Exam Gloves	Hebei Grandeast Plastic Products Co., Ltd.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	5	0
2006	4	0
2007	6	0
2008	3	0
2009	19	0
2010	23	0
2011	12	0
2012	11	0
2013	4	0
2014	26	0
2015	4	0
2016	2	0
2017	3	0
2018	2	0
2019	2	0
2021	3	0
2022	1	0

FIG. 1 — Lineage of K032908, 2000–2022Source: 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? (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	Applicant	Decided	Recalls
*	K000071	Synthetic Powder Free (White) Vinyl Patient Examination Gloves	Shijiazhuang Great Eagle Plastic Products Co., Ltd.	2000	—

Also cleared against K000071: 8 other devices →

What descends from it? (130)

See all 130

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

Number	Device	Applicant	Decided	Descendants
K091663	Powder-Free Vinyl Patient Examination Gloves	Zhangjiagang Fengyuan Plastic Products Co., Ltd.	2009	20
K120968	Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Tangshan Zhonghong Pulin Plastic Co.,Ltd	2012	19
K100699	Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Star Plastic Co., Ltd.	2010	9
K110944	Powder-Free Vinyl Patient Examination Gloves	Wangda Plastic Co., Ltd.	2011	4
K070149	Powder-Free Vinyl Patient Examination Gloves	Wuxi Shenzhou Plastic Products Co., Ltd.	2007	2
K073193	Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Prosperous Plastic Co., Ltd.	2007	1
K062522	Powder-Free Vinyl Patient Examination Gloves	Jiangsu Jaysun Glove Co., Ltd.	2006	1
K130742	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Dahoon Plastic Co., Ltd.	2014	0
K130751	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Cabin Plastic Co., Ltd.	2014	0
K130800	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Kaixuan Plastic Co., Ltd.	2014	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?

Its one ancestor has no recall.
Of its descendants, K091663 (Zhangjiagang Fengyuan Plastic Products Co., Ltd., 2009) has gone furthest, with 20 descendants of its own.
8 other devices also cite its predicate K000071.

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?

Powder free 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/K032908 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032908: Fuguan (Brand) 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/K032908

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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