510(k) · Cleared

Cleared

Powder Free Sterile Vinyl Glove (Clear and Yellow)

K053523510(k) TraditionalCleared Feb 14, 200657-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 Hongxiang Plastics Products Co., Ltd. · LYZ Vinyl Patient Examination Glove

Cleared on Feb 14, 2006 as substantially equivalent to K992861 (Shijiazhuang Great Eagle Plastic Products Co., Ltd., 1999) after a 57-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.

Decided: Feb 14, 2006
Review: 57 days
Class: Class I
Product code: LYZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K992861 (1999). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK992861 Synthetic Powder Free (Yellow) Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 1999
This deviceK053523 Powder Free Sterile Vinyl Glove (Clear and Yellow)Shijiazhuang Hongxiang Plastics Products Co., Ltd. · 2006
Descendant · cites it directly · 0 of its ownK170612 STERILE VINYL EXAMINATION GLOVES, Powder FreePrimus Gloves Pvt Limited · 2017

Most influential descendants

Showing 1 of 1 · See all

K170612STERILE VINYL EXAMINATION GLOVES, Powder FreePrimus Gloves Pvt Limited · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K992861	Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves	Shijiazhuang Great Eagle Plastic Products Co., Ltd.	1999	—
0 (this device)	K053523	Powder Free Sterile Vinyl Glove (Clear and Yellow)	Shijiazhuang Hongxiang Plastics Products Co., Ltd.	2006	—
+1	K170612	STERILE VINYL EXAMINATION GLOVES, Powder Free	Primus Gloves Pvt Limited	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K053523, 1999–2017Source: 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
*	K992861	Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves Summary page 1 …3. Predicate Device Information: Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves (K992861) 4. Device Description: Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.62…	Shijiazhuang Great Eagle Plastic Products Co., Ltd.	1999	—

Also cleared against K992861: 10 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K170612	STERILE VINYL EXAMINATION GLOVES, Powder Free	Primus Gloves Pvt Limited	2017	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, K170612 (Primus Gloves Pvt Limited, 2017) has gone furthest, with 0 descendants of its own.
10 other devices also cite its predicate K992861.

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?

A patient examination glove is disposable device intended for medical a purpose 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/K053523 · printed Nov 5, 2026

Cite this page

510(k) Report. “K053523: Powder Free Sterile Vinyl Glove (Clear and Yellow).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053523

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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