510(k) · Cleared

Cleared

Disposable Powder Free Vinyl Synthetic Exam Glove, White Color

K072377510(k) AbbreviatedCleared Dec 14, 2007112-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

Xuzhou Full Sun Medical Products, Ltd. · LYZ Vinyl Patient Examination Glove

Cleared on Dec 14, 2007 as substantially equivalent to K033835 (Mdm Enterprise Corp., 2004) after a 112-day review. Its family tree reaches back 1 generation to 2004.

Decided: Dec 14, 2007
Review: 112 days
Class: Class I
Product code: LYZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K033835 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK033835 Disposable Powder Free Vinyl Synthetic Examination Glove, White ColorMdm Enterprise Corp. · 2004
This deviceK072377 Disposable Powder Free Vinyl Synthetic Exam Glove, White ColorXuzhou Full Sun Medical Products, Ltd. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K033835	Disposable Powder Free Vinyl Synthetic Examination Glove, White Color	Mdm Enterprise Corp.	2004	—
0 (this device)	K072377	Disposable Powder Free Vinyl Synthetic Exam Glove, White Color	Xuzhou Full Sun Medical Products, Ltd.	2007	—

FIG. 1 — Lineage of K072377, 2004–2007Source: 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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K033835	Disposable Powder Free Vinyl Synthetic Examination Glove, White Color Summary page 1 …thetic Excam Gloves, White Color 3. Predicate Device Information: TMDM ENTERPRISE CORP. Disposable Powder Free Vinyl Synthetic'Exarnination Glove, White Color (K033835) 4. Device description: Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-F…	Mdm Enterprise Corp.	2004	—

Also cleared against K033835: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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.
1 other device also cites its predicate K033835.

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. 2007, 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?

A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072377 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072377: Disposable Powder Free Vinyl Synthetic Exam Glove, White Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072377

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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