510(k) · Cleared

Cleared

Synthetic Powder Free (White) Vinyl Patient Examination Gloves

K000071510(k) TraditionalCleared Feb 29, 200050-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 Great Eagle Plastic Products Co., Ltd. · LYZ Vinyl Patient Examination Glove

Cleared on Feb 29, 2000 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 139 later devices descend from it.

Decided: Feb 29, 2000
Review: 50 days
Class: Class I
Product code: LYZ
Recalls: None
Predicates: 0

139 later devices descend from it, 9 citing it directly.

This deviceK000071 Synthetic Powder Free (White) Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 2000
Descendant · cites it directly · 130 of its ownK032908 Fuguan (Brand) Powder-Free Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003
Descendant · 2 generations on · 20 of its ownK091663 Powder-Free Vinyl Patient Examination GlovesZhangjiagang Fengyuan Plastic Products Co., Ltd. · 2009
Descendant · 2 generations on · 19 of its ownK120968 Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Tangshan Zhonghong Pulin Plastic Co.,Ltd · 2012 · Recalled
Descendant · 2 generations on · 9 of its ownK100699 Powder-Free Vinyl Patient Examination GlovesShijiazhuang Star Plastic Co., Ltd. · 2010
Descendant · 3 generations on · 5 of its ownK130733 Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Benteng Plastic Co., Ltd. · 2014

Showing 5 of 139 descendants. See all descendants

Descendants cleared per year

2003high 26 (2014) · low 0 (2020)2026

Most influential descendants

Showing 5 of 139 · See all

K032908Fuguan (Brand) Powder-Free Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003 · cites it directly130descendants
K091663Powder-Free Vinyl Patient Examination GlovesZhangjiagang Fengyuan Plastic Products Co., Ltd. · 2009 · 2 generations on20descendants
K120968Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Tangshan Zhonghong Pulin Plastic Co.,Ltd · 2012 · 2 generations on19descendants
K100699Powder-Free Vinyl Patient Examination GlovesShijiazhuang Star Plastic Co., Ltd. · 2010 · 2 generations on9descendants
K130733Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Benteng Plastic Co., Ltd. · 2014 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	4	0
2004	1	0
2005	5	0
2006	5	0
2007	9	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 K000071, 2000–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (139)

See all 139

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

Number	Device	Applicant	Decided	Descendants
K032908	Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Fuguan Plastic Products Co., Ltd.	2003	130
K070041	Powdered Free (White) Vinyl Patient Examination Gloves	Shijiazhuang Lianhe Shunda Plastic Products Co., L	2007	0
K063471	Shijiazhuang Junfei Plastics Products CO., LTD. Powder Free (White) Vinyl Patient…	Shijiazhuang Junfei Plastic Products Co., Ltd.	2007	0
K070043	Powder Free Vinyl Patient Examination Gloves, White	Super Safe Plastic Products Co., Ltd.	2007	0
K063213	Ever Light Plastic Products CO., LTD. Powder Free (White) Vinyl Patient Examination Gloves	Ever Light Plastic Products Co., Ltd.	2006	0
K040681	Synthetic (White) Vinyl Patient Examination Gloves-Powder Free	Grand Work Plastic Products Co., Ltd.	2004	0
K032781	Blue Sail (Brand) Powder-Free Vinyl Patient Examination Gloves	Zibo Blue Sail Plastic & Rubber Products Co., Ltd.	2003	0
K031108	Synthetic (White) Vinyl Patient Examination Gloves-Powder Free	Shijiazhuang Great Vision Plastic Products Co., LT	2003	0
K031293	Synthetic (White) Vinyl Patient Examination Gloves-Powder Free	Shijiazhuang Eversharp Plastic Products Co., Ltd.	2003	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?

Of its descendants, K032908 (Shijiazhuang Fuguan Plastic Products Co., Ltd., 2003) has gone furthest, with 130 descendants of its own.

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	—

https://510kreport.com/device/K000071 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000071: Synthetic Powder Free (White) 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/K000071

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026