510(k) · Cleared

Cleared

Jinhua Latex Exam Glove, Powder Free with Protein Labeling

K964845510(k) TraditionalCleared Feb 27, 199786-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

Jinhua Latex Products Factory · LYY Latex Patient Examination Glove

Cleared on Feb 27, 1997 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided: Feb 27, 1997
Review: 86 days
Class: Class I
Product code: LYY
Recalls: None
Predicates: 0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K964845Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LYY? 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 LYY device

#1 K202377 Palm Care Latex Examination Powder Free Glovesscore 12.7 · 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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.

How does its category compare?

All LYY devices

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

FDA decisions per year · LYY

1in 2025

2007high 14 (2022) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYY

150in 2022

2007high 251 (2015) · low 75 (2007)2026

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

Recalls per year · LYY

1in 2020

2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · LYY

1in 2025

2007high 14 (2008) · low 0 (2018)2025

MAUDE reports naming product code LYY, 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	12	75	0	11
2008	13	151	0	14
2009	7	76	0	11
2010	13	106	0	10
2011	11	127	1	4
2012	11	133	0	1
2013	6	131	0	2
2014	3	156	0	6
2015	3	251	0	5
2016	4	142	0	7
2017	4	230	0	7
2018	2	—	0	0
2019	1	—	0	7
2020	1	—	1	1
2021	8	188	0	1
2022	14	150	0	0
2023	2	—	0	0
2024	1	—	0	6
2025	1	—	0	1
2026	0	—	0	—

https://510kreport.com/device/K964845 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964845: Jinhua Latex Exam Glove, Powder Free with Protein Labeling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964845

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026