510(k) · Cleared

Cleared

Baldur Brand Vinyl Powder-Free Examination Gloves

K022091510(k) TraditionalCleared Dec 30, 2002186-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

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

Cleared on Dec 30, 2002 after a 186-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.

Decided: Dec 30, 2002
Review: 186 days
Class: Class I
Product code: LYZ
Recalls: None
Predicates: 0

9 later devices descend from it, 9 citing it directly.

This deviceK022091 Baldur Brand Vinyl Powder-Free Examination GlovesTangshan Zhonghong Pulin Group Co., Ltd. · 2002
Descendant · cites it directly · 0 of its ownK191092 Powder-Free Vinyl Patient Examination Gloves, Yellow ColorAnhui Intco Medical Products Co., Ltd. · 2019
Descendant · cites it directly · 0 of its ownK190095 Powder-Free Clear Vinyl Patient Examination GlovesAnhui Intco Medical Products Co., Ltd. · 2019
Descendant · cites it directly · 0 of its ownK171460 Powder-free Clear Vinyl Patient Examination GlovesShandong Zhiwei Medical Products, Co., Ltd. · 2017
Descendant · cites it directly · 0 of its ownK161390 Vinyl Exam Gloves, Powder Free, ClearZibo Hongchin Plastic and Rubber Co., Ltd. · 2016
Descendant · cites it directly · 0 of its ownK142892 Powder-free Clear Vinyl Patient Examination GlovesShenyi (Shandong) Plastic Products Co., Ltd. · 2015

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2012high 2 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 9 · See all

K191092Powder-Free Vinyl Patient Examination Gloves, Yellow ColorAnhui Intco Medical Products Co., Ltd. · 2019 · cites it directly0descendants
K190095Powder-Free Clear Vinyl Patient Examination GlovesAnhui Intco Medical Products Co., Ltd. · 2019 · cites it directly0descendants
K171460Powder-free Clear Vinyl Patient Examination GlovesShandong Zhiwei Medical Products, Co., Ltd. · 2017 · cites it directly0descendants
K161390Vinyl Exam Gloves, Powder Free, ClearZibo Hongchin Plastic and Rubber Co., Ltd. · 2016 · cites it directly0descendants
K142892Powder-free Clear Vinyl Patient Examination GlovesShenyi (Shandong) Plastic Products Co., Ltd. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K022091	Baldur Brand Vinyl Powder-Free Examination Gloves	Tangshan Zhonghong Pulin Group Co., Ltd.	2002	—
+1	K191092	Powder-Free Vinyl Patient Examination Gloves, Yellow Color	Anhui Intco Medical Products Co., Ltd.	2019	—
+1	K190095	Powder-Free Clear Vinyl Patient Examination Gloves	Anhui Intco Medical Products Co., Ltd.	2019	—
+1	K171460	Powder-free Clear Vinyl Patient Examination Gloves	Shandong Zhiwei Medical Products, Co., Ltd.	2017	—
+1	K161390	Vinyl Exam Gloves, Powder Free, Clear	Zibo Hongchin Plastic and Rubber Co., Ltd.	2016	—
+1	K142892	Powder-free Clear Vinyl Patient Examination Gloves	Shenyi (Shandong) Plastic Products Co., Ltd.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	2	0
2014	2	0
2015	1	0
2016	1	0
2017	1	0
2019	2	0

FIG. 1 — Lineage of K022091, 2002–2019Source: 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
*	—	Class I vinyl patient examination gloves, powder-free, that meet all the requirements of… Named without a submission number			—

What descends from it? (9)

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

Number	Device	Applicant	Decided
K191092	Powder-Free Vinyl Patient Examination Gloves, Yellow Color	Anhui Intco Medical Products Co., Ltd.	2019
K190095	Powder-Free Clear Vinyl Patient Examination Gloves	Anhui Intco Medical Products Co., Ltd.	2019
K171460	Powder-free Clear Vinyl Patient Examination Gloves	Shandong Zhiwei Medical Products, Co., Ltd.	2017
K161390	Vinyl Exam Gloves, Powder Free, Clear	Zibo Hongchin Plastic and Rubber Co., Ltd.	2016
K142892	Powder-free Clear Vinyl Patient Examination Gloves	Shenyi (Shandong) Plastic Products Co., Ltd.	2015
K132221	Powder-Free Vinyl Patient Examination Gloves	Shandong Haoyu Medical Products Co., Ltd.	2014
K131832	Powder-Free Vinyl Patient Examination Gloves	Shandong Binxiang Medical Products Co., Ltd.	2014
K120230	Powder-Free Vinyl Patient Examination Gloves, Non-Sterile	Shandong Taixiang Medical Products Co., Ltd.	2012
K110536	Powder-Free Vinyl Patient Examination Gloves	Zibo Tengyue Plastic Products Co., Ltd.	2012

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, K191092 (Anhui Intco Medical Products Co., Ltd., 2019) has gone furthest, with 0 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	—

What is it indicated for?

A Vinyl patient examination glove is a disposable device intended for medical purposes 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/K022091 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022091: Baldur Brand Vinyl Powder-Free Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022091

Report an extraction error

Are you the manufacturer?

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