510(k) · Cleared

Cleared

Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination Glove

K071072510(k) TraditionalCleared Aug 30, 2007136-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

Shanghai China Star Corp · LZA Polymer Patient Examination Glove

Cleared on Aug 30, 2007 as substantially equivalent to K040841 (Medline Industries, Inc., 2004) and 1 other predicate after a 136-day review. Its family tree reaches back 1 generation to 2002. 6 later devices descend from it.

Decided: Aug 30, 2007
Review: 136 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K022765 (2002). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
This deviceK071072 Shanghai China Star Corp. Powder Free Blue Nitrile Patient…Shanghai China Star Corp · 2007
Descendant · cites it directly · 5 of its ownK090336 Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient…Sunmax Enterprise Shanghai Co., Ltd. · 2009
Descendant · 2 generations on · 1 of its ownK102593 Synthetic, Powder-Free Nitrile ExaminationZibo Yinghao Medical Products Co., Ltd. · 2010
Descendant · 2 generations on · 1 of its ownK101870 Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination GloveSunmax Vietnam Co., Ltd. · 2010
Descendant · 3 generations on · 0 of its ownK211667 Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)Changzhou Universal Medical Equipment Co., Ltd. · 2021
Descendant · 3 generations on · 0 of its ownK103675 Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination GloveChienmax Vietnam Co., Ltd. · 2011

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009high 3 (2010) · low 0 (2012)2026

Most influential descendants

Showing 5 of 6 · See all

K090336Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested…Sunmax Enterprise Shanghai Co., Ltd. · 2009 · cites it directly5descendants
K102593Synthetic, Powder-Free Nitrile ExaminationZibo Yinghao Medical Products Co., Ltd. · 2010 · 2 generations on1descendant
K101870Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination GloveSunmax Vietnam Co., Ltd. · 2010 · 2 generations on1descendant
K211667Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)Changzhou Universal Medical Equipment Co., Ltd. · 2021 · 3 generations on0descendants
K103675Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination GloveChienmax Vietnam Co., Ltd. · 2011 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K022765	Nitrile Powder-Free Examination Gloves	Allegiance Healthcare Corp.	2002	—
0 (this device)	K071072	Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination Glove	Shanghai China Star Corp	2007	—
+1	K090336	Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination…	Sunmax Enterprise Shanghai Co., Ltd.	2009	—
+2	K102593	Synthetic, Powder-Free Nitrile Examination	Zibo Yinghao Medical Products Co., Ltd.	2010	—
+2	K101870	Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination Glove	Sunmax Vietnam Co., Ltd.	2010	—
+3	K211667	Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)	Changzhou Universal Medical Equipment Co., Ltd.	2021	—
+3	K103675	Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination Glove	Chienmax Vietnam Co., Ltd.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	3	0
2011	1	0
2021	1	0

FIG. 1 — Lineage of K071072, 2002–2021Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K040841	Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) Summary page 2 …LEGIANCE and parameters Corp INDUSTRIES, INC HEALTHCARE (New Device) (K) 040841 CORP. (K) 022765 Product Code…	Medline Industries, Inc.	2004	—
*	K022765	Nitrile Powder-Free Examination Gloves Summary page 2 …(New Device) (K) 040841 CORP. (K) 022765 Product Code LZA LZA LZA Intended Use A powder free pat…	Allegiance Healthcare Corp.	2002	—

Also cleared against K040841: 1 other device →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K090336	Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested…	Sunmax Enterprise Shanghai Co., Ltd.	2009	5

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?

None of the 2 ancestors has a recall.
Of its descendants, K090336 (Sunmax Enterprise Shanghai Co., Ltd., 2009) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K040841.

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. 2007, this device’s year, is highlighted.

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?

A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071072 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071072: Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071072

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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