510(k) · Cleared

Cleared

Nirtrile Patient Examination Glove (Blue Color) Powdered, Non Sterile

K002818510(k) TraditionalCleared Nov 29, 2000117-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

Siam Sempermed Corp., Ltd. · LZA Polymer Patient Examination Glove

Cleared on Nov 29, 2000 after a 117-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Nov 29, 2000
Review: 117 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK002818 Nirtrile Patient Examination Glove (Blue Color) Powdered, Non SterileSiam Sempermed Corp., Ltd. · 2000
Descendant · cites it directly · 0 of its ownK081911 Non-Sterile, Powdered Nitrile Examination Glove, BlueSiam Sempermed Corp., Ltd. · 2009

Most influential descendants

Showing 1 of 1 · See all

K081911Non-Sterile, Powdered Nitrile Examination Glove, BlueSiam Sempermed Corp., Ltd. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002818	Nirtrile Patient Examination Glove (Blue Color) Powdered, Non Sterile	Siam Sempermed Corp., Ltd.	2000	—
+1	K081911	Non-Sterile, Powdered Nitrile Examination Glove, Blue	Siam Sempermed Corp., Ltd.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K002818, 2000–2009Source: FDA 510(k) summaries, read by 510(k) Report · 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 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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
K081911	Non-Sterile, Powdered Nitrile Examination Glove, Blue	Siam Sempermed Corp., Ltd.	2009	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?

Of its descendants, K081911 (Siam Sempermed Corp., Ltd., 2009) has gone furthest, with 0 descendants of its own.

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.

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	—

https://510kreport.com/device/K002818 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002818: Nirtrile Patient Examination Glove (Blue Color) Powdered, Non Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002818

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026