510(k) · Cleared

Cleared

Non-Sterile, Powder Free Green Latex Examination Gloves with or Without Sour Apple or Peppermint Scenting Plus a Protein

K032293510(k) TraditionalCleared Aug 28, 200334-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

Sgmp Co., Ltd. · LYY Latex Patient Examination Glove

Cleared on Aug 28, 2003 as substantially equivalent to K011370 (Sgmp Co., Ltd., 2001) after a 34-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Aug 28, 2003
Review: 34 days
Class: Class I
Product code: LYY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011370 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011370 Non-Sterile Powder Free Purple Latex Examination Glove with and…Sgmp Co., Ltd. · 2001
This deviceK032293 Non-Sterile, Powder Free Green Latex Examination Gloves with or…Sgmp Co., Ltd. · 2003
Descendant · cites it directly · 0 of its ownK052666 Non-Sterile Powder Free Natural/Green Lano-E Latex Exam Gloves, with…Ascend Eagle, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K052666Non-Sterile Powder Free Natural/Green Lano-E Latex Exam Gloves, with or Wihout…Ascend Eagle, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011370	Non-Sterile Powder Free Purple Latex Examination Glove with and Without Grape…	Sgmp Co., Ltd.	2001	—
0 (this device)	K032293	Non-Sterile, Powder Free Green Latex Examination Gloves with or Without Sour…	Sgmp Co., Ltd.	2003	—
+1	K052666	Non-Sterile Powder Free Natural/Green Lano-E Latex Exam Gloves, with or Wihout…	Ascend Eagle, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K032293, 2001–2006Source: 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 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? (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
*	K011370	Non-Sterile Powder Free Purple Latex Examination Glove with and Without Grape Scent and… Summary page 1 …i I I C l,ei-iai? i!:oi ti’d? Equivalent Predicate Device: POWDER FREE PURPLE LATEX EXAM GLOVES WITH AND WITHOUT GRAPE SCENTING which was approved for marketing as K011370. This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. Devi…	Sgmp Co., Ltd.	2001	—

Also cleared against K011370: 1 other device →

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
K052666	Non-Sterile Powder Free Natural/Green Lano-E Latex Exam Gloves, with or Wihout…	Ascend Eagle, Inc.	2006	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, K052666 (Ascend Eagle, Inc., 2006) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K011370.

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	—

What is it indicated for?

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032293 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032293: Non-Sterile, Powder Free Green Latex Examination Gloves with or Without Sour Apple or Peppermint Scenting Plus a Protein.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032293

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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