510(k) · Cleared

Cleared

Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color)

K051662510(k) TraditionalCleared Jul 22, 200530-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

Grand Work Plastic Products Co., Ltd. · LZA Polymer Patient Examination Glove

Cleared on Jul 22, 2005 after a 30-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 12 later devices descend from it.

Decided: Jul 22, 2005
Review: 30 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 1

12 later devices descend from it, 2 citing it directly.

This deviceK051662 Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color)Grand Work Plastic Products Co., Ltd. · 2005
Descendant · cites it directly · 10 of its ownK153028 Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, BlueZibo Huiying Medical Products, Co., Ltd. · 2016
Descendant · 2 generations on · 1 of its ownK211262 Disposable Vinyl Nitrile Synthetic Gloves Powder FreeTangshan Hongyun Healthcare Products Co., Ltd. · 2021
Descendant · cites it directly · 0 of its ownK213574 Nitrile Vinyl Blend Powder Free Examination Gloves (Black)Grand Work Plastic Products Co., Ltd. · 2022
Descendant · 2 generations on · 0 of its ownK213634 Vinyl/Nitrile Blend Exam GloveDezhou Hengchang Medical Technology Co., Ltd. · 2022
Descendant · 2 generations on · 0 of its ownK212436 NBR Synthetic Nitrile Examination GlovesShandong Langtai International Trade Co., Ltd. · 2021

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2016high 9 (2021) · low 0 (2017)2026

Most influential descendants

Showing 5 of 12 · See all

K153028Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, BlueZibo Huiying Medical Products, Co., Ltd. · 2016 · cites it directly10descendants
K211262Disposable Vinyl Nitrile Synthetic Gloves Powder FreeTangshan Hongyun Healthcare Products Co., Ltd. · 2021 · 2 generations on1descendant
K213574Nitrile Vinyl Blend Powder Free Examination Gloves (Black)Grand Work Plastic Products Co., Ltd. · 2022 · cites it directly0descendants
K213634Vinyl/Nitrile Blend Exam GloveDezhou Hengchang Medical Technology Co., Ltd. · 2022 · 2 generations on0descendants
K212436NBR Synthetic Nitrile Examination GlovesShandong Langtai International Trade Co., Ltd. · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K051662	Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color)	Grand Work Plastic Products Co., Ltd.	2005	—
+1	K153028	Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue	Zibo Huiying Medical Products, Co., Ltd.	2016	—
+2	K211262	Disposable Vinyl Nitrile Synthetic Gloves Powder Free	Tangshan Hongyun Healthcare Products Co., Ltd.	2021	—
+1	K213574	Nitrile Vinyl Blend Powder Free Examination Gloves (Black)	Grand Work Plastic Products Co., Ltd.	2022	—
+2	K213634	Vinyl/Nitrile Blend Exam Glove	Dezhou Hengchang Medical Technology Co., Ltd.	2022	—
+2	K212436	NBR Synthetic Nitrile Examination Gloves	Shandong Langtai International Trade Co., Ltd.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2021	9	0
2022	2	0

FIG. 1 — Lineage of K051662, 2005–2022Source: 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 LZA? 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 LZA device

#1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K011882	FDA’s K011882 is Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Shijiazhuang Eversharp Plastic Products Co., Ltd.	2001	—

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K153028	Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue	Zibo Huiying Medical Products, Co., Ltd.	2016	10
K213574	Nitrile Vinyl Blend Powder Free Examination Gloves (Black)	Grand Work Plastic Products Co., Ltd.	2022	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, K153028 (Zibo Huiying Medical Products, Co., Ltd., 2016) has gone furthest, with 10 descendants of its own.

How does its category compare?

All LZA devices

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

FDA decisions per year · LZA

24in 2025

2007high 146 (2022) · low 18 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZA

110in 2025

2007high 212 (2019) · low 89 (2024)2026

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

Recalls per year · LZA

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · LZA

73in 2025

2007high 76 (2024) · low 2 (2008)2025

MAUDE reports naming product code LZA, 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	21	95	0	7
2008	18	97	0	2
2009	28	112	0	12
2010	31	97	0	12
2011	26	122	0	9
2012	33	110	0	11
2013	20	130	0	10
2014	27	197	0	8
2015	20	112	1	12
2016	30	171	1	25
2017	44	124	0	4
2018	22	178	0	3
2019	25	212	0	21
2020	30	101	0	4
2021	139	111	0	20
2022	146	111	0	19
2023	62	92	0	24
2024	30	89	0	76
2025	24	110	0	73
2026	15	103	3	—

What is it indicated for?

The Vinyl Plastic Co-Polymer Powder-Free Examination Gloves (Blue Color) is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051662 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051662: Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051662

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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