510(k) · Cleared

Cleared

Powder-Free Vinyl Patient Examination Gloves

K964964510(k) TraditionalCleared Feb 7, 199758-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

Sunmax Enterprise Shanghai Co., Ltd. · LYZ Vinyl Patient Examination Glove

Cleared on Feb 7, 1997 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 36 later devices descend from it.

Decided: Feb 7, 1997
Review: 58 days
Class: Class I
Product code: LYZ
Recalls: None
Predicates: 0

36 later devices descend from it, 5 citing it directly.

This deviceK964964 Powder-Free Vinyl Patient Examination GlovesSunmax Enterprise Shanghai Co., Ltd. · 1997
Descendant · cites it directly · 18 of its ownK992821 Synthetic Powder-Free Vinyl Patient Examination GlovesShijiazhuang Hongxiang Plastics Products Co., Ltd. · 2000 · Recalled
Descendant · cites it directly · 8 of its ownK983207 Synthetic Powder-Free Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 1998
Descendant · cites it directly · 4 of its ownK974120 Powder-Free Vinyl Patient Examination GlovesShanghai Super Gloves Co., Ltd. · 1997
Descendant · 2 generations on · 2 of its ownK092296 Powder Free Examination GloveBettercare Plastic Products Co., Ltd. · 2009
Descendant · 2 generations on · 2 of its ownK984460 Powder-Free Vinyl Patient Examination GlovesShanghai Huamao Gloves Co., Ltd. · 1999

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

1997high 8 (2009) · low 0 (2002)2026

Most influential descendants

Showing 5 of 36 · See all

K992821Synthetic Powder-Free Vinyl Patient Examination GlovesShijiazhuang Hongxiang Plastics Products Co., Ltd. · 2000 · cites it directly18descendants
K983207Synthetic Powder-Free Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 1998 · cites it directly8descendants
K974120Powder-Free Vinyl Patient Examination GlovesShanghai Super Gloves Co., Ltd. · 1997 · cites it directly4descendants
K092296Powder Free Examination GloveBettercare Plastic Products Co., Ltd. · 2009 · 2 generations on2descendants
K984460Powder-Free Vinyl Patient Examination GlovesShanghai Huamao Gloves Co., Ltd. · 1999 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K964964	Powder-Free Vinyl Patient Examination Gloves	Sunmax Enterprise Shanghai Co., Ltd.	1997	—
+1	K992821	Synthetic Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Hongxiang Plastics Products Co., Ltd.	2000	1
+1	K983207	Synthetic Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Great Eagle Plastic Products Co., Ltd.	1998	—
+1	K974120	Powder-Free Vinyl Patient Examination Gloves	Shanghai Super Gloves Co., Ltd.	1997	—
+2	K092296	Powder Free Examination Glove	Bettercare Plastic Products Co., Ltd.	2009	—
+2	K984460	Powder-Free Vinyl Patient Examination Gloves	Shanghai Huamao Gloves Co., Ltd.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	5	0
2000	2	0
2001	1	0
2004	1	0
2007	3	0
2009	8	0
2010	6	0
2011	2	0
2012	1	0
2013	1	0
2014	3	0
2015	1	0

FIG. 1 — Lineage of K964964, 1997–2015Source: 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

Get a 510(k) Report

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? (36)

See all 36

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

Number	Device	Applicant	Decided	Descendants
K992821	Synthetic Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Hongxiang Plastics Products Co., Ltd.	2000	18
K983207	Synthetic Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Great Eagle Plastic Products Co., Ltd.	1998	8
K974120	Powder-Free Vinyl Patient Examination Gloves	Shanghai Super Gloves Co., Ltd.	1997	4
K992555	Synthetic Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Great Vision Plastic Products Co., LT	1999	1
K992463	Synthetic Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Dilly Plastics Products Co., Ltd.	1999	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, K992821 (Shijiazhuang Hongxiang Plastics Products Co., Ltd., 2000) has gone furthest, with 18 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/K964964 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964964: 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/K964964

Report an extraction error

Are you the manufacturer?

Record history

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