510(k) · Cleared

Cleared

Non-Sterile, Powdered Nitrile Examination Glove, Blue

K081911510(k) AbbreviatedCleared Jan 15, 2009196-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 Jan 15, 2009 as substantially equivalent to K002818 (Siam Sempermed Corp., Ltd., 2000) after a 196-day review. Its family tree reaches back 1 generation to 2000.

Decided: Jan 15, 2009
Review: 196 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002818 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK002818 Nirtrile Patient Examination Glove (Blue Color) Powdered, Non SterileSiam Sempermed Corp., Ltd. · 2000
This deviceK081911 Non-Sterile, Powdered Nitrile Examination Glove, BlueSiam Sempermed Corp., Ltd. · 2009

View FIG. 1 as a table

Line of descent and top descendants

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

FIG. 1 — Lineage of K081911, 2000–2009Source: 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

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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
*	K002818	Nirtrile Patient Examination Glove (Blue Color) Powdered, Non Sterile Summary page 2 …n the tabulated comparison as below. Technical comparison of specific elements is attached in the main submission. FDA file reference number 510k number: K002818 Attachments inside notification REFER TO APPENDIX I submission file ,_............ TECHNOLOGICAL…	Siam Sempermed Corp., Ltd.	2000	—

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.

What does this lineage say?

Its one ancestor has no recall.

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. 2009, 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 patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081911 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081911: Non-Sterile, Powdered Nitrile Examination Glove, Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081911

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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