510(k) · Cleared

Recalled · Class II · 2016

Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)

K120968510(k) TraditionalCleared Sep 19, 2012173-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

Tangshan Zhonghong Pulin Plastic Co.,Ltd · LYZ Vinyl Patient Examination Glove

Cleared on Sep 19, 2012 as substantially equivalent to K032908 (Shijiazhuang Fuguan Plastic Products Co., Ltd., 2003) after a 173-day review. Its family tree reaches back 2 generations to 2000. 19 later devices descend from it. It has been recalled once.

Decided: Sep 19, 2012
Review: 173 days
Class: Class I
Product code: LYZ
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K000071 (2000). 19 later devices descend from it, 14 citing it directly.

By dateBy generation

Root · 2 generations backK000071 Synthetic Powder Free (White) Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 2000
1 generation backK032908 Fuguan (Brand) Powder-Free Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003
This deviceK120968 Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Tangshan Zhonghong Pulin Plastic Co.,Ltd · 2012
Descendant · cites it directly · 5 of its ownK130733 Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Benteng Plastic Co., Ltd. · 2014
Descendant · 2 generations on · 4 of its ownK142703 Powder-free PVC Vinyl Exam GlovesHebei Grandeast Plastic Products Co., Ltd. · 2015
Descendant · 3 generations on · 0 of its ownK173078 Powder-free Clear Vinyl Patient Examination GlovesYongsheng Medical Products Co., Ltd. · 2018
Descendant · 3 generations on · 0 of its ownK171317 Clear Vinyl Powder-free Patient Examination GlovesShandong Zhi Hong Medical Products, Co., Ltd. · 2017
Descendant · 3 generations on · 0 of its ownK170735 Powder-Free Clear Vinyl Patient Examination GlovesZibo Yue Fan Medical Products Co, Ltd. · 2017

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2014high 13 (2014) · low 0 (2019)2026

Most influential descendants

Showing 5 of 19 · See all

K130733Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Benteng Plastic Co., Ltd. · 2014 · cites it directly5descendants
K142703Powder-free PVC Vinyl Exam GlovesHebei Grandeast Plastic Products Co., Ltd. · 2015 · 2 generations on4descendants
K173078Powder-free Clear Vinyl Patient Examination GlovesYongsheng Medical Products Co., Ltd. · 2018 · 3 generations on0descendants
K171317Clear Vinyl Powder-free Patient Examination GlovesShandong Zhi Hong Medical Products, Co., Ltd. · 2017 · 3 generations on0descendants
K170735Powder-Free Clear Vinyl Patient Examination GlovesZibo Yue Fan Medical Products Co, Ltd. · 2017 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	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	—
0 (this device)	K120968	Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Tangshan Zhonghong Pulin Plastic Co.,Ltd	2012	—
+1	K130733	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Benteng Plastic Co., Ltd.	2014	—
+2	K142703	Powder-free PVC Vinyl Exam Gloves	Hebei Grandeast Plastic Products Co., Ltd.	2015	—
+3	K173078	Powder-free Clear Vinyl Patient Examination Gloves	Yongsheng Medical Products Co., Ltd.	2018	—
+3	K171317	Clear Vinyl Powder-free Patient Examination Gloves	Shandong Zhi Hong Medical Products, Co., Ltd.	2017	—
+3	K170735	Powder-Free Clear Vinyl Patient Examination Gloves	Zibo Yue Fan Medical Products Co, Ltd.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	13	0
2015	2	0
2016	1	0
2017	2	0
2018	1	0

FIG. 1 — Lineage of K120968, 2000–2018Source: 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
*	K032908	Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves Summary page 1 …requirements of ASTM standard D 5250-06. Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 . [(a)(4)j A description of the device Device Description : powder free vinyl patient examination gloves, Clear(non-colored) th…	Shijiazhuang Fuguan Plastic Products Co., Ltd.	2003	—

Also cleared against K032908: 74 other devices →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K130733	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Benteng Plastic Co., Ltd.	2014	5
K143715	Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)	Better Plastic Co., Ltd.	2015	0
K142342	NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored)	Nacrous Plastic Co., Ltd.	2014	0
K142343	Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear ( Non-colored)	Tangshan Hongyun Plastic Products Co., Ltd.	2014	0
K140244	Yonghe	Yonghe Plastic Products Co., Ltd.	2014	0
K140246	Yongfa	Yongfa Glove Co., Ltd.	2014	0
K141108	Yusheng	Zibo Yusheng Plastic Products Co., Ltd.	2014	0
K141305	Richful Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Shijiazhuang Richful Plastic Co., Ltd.	2014	0
K141307	Aok Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Shijiazhuang Aok Plastic Co., Ltd.	2014	0
K140243	Shuntong	Shuntong Glove Co., Ltd.	2014	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 12, 2016	Class II	Z-0741-2017	Process control	A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K130733 (Benteng Plastic Co., Ltd., 2014) has gone furthest, with 5 descendants of its own.
74 other devices also cite its predicate K032908.

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. 2012, this device’s year, is highlighted.

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 vinyi patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's band or finger to prevent contamination between patient and examiner.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120968 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120968: Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120968

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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