510(k) · Cleared

Cleared

Non-Sterile, Powder Free Latex Examination Gloves and Protein Claim (50 Micrograms or Less) Model: White: X-Small, Small

K100907510(k) AbbreviatedCleared Jul 9, 201099-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. · LYY Latex Patient Examination Glove

Cleared on Jul 9, 2010 as substantially equivalent to K970794 (Siam Sempermed Corp., Ltd., 1997) after a 99-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Jul 9, 2010
Review: 99 days
Class: Class I
Product code: LYY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970794 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK970794 Latex Patient Examination (Powderfree Glove)Siam Sempermed Corp., Ltd. · 1997
This deviceK100907 Non-Sterile, Powder Free Latex Examination Gloves and Protein Claim…Siam Sempermed Corp., Ltd. · 2010
Descendant · cites it directly · 0 of its ownK111133 Non-Sterile, Powder Free Latex Examination Gloves with Protein Claim…Ssc Surat Thani · 2011

Most influential descendants

Showing 1 of 1 · See all

K111133Non-Sterile, Powder Free Latex Examination Gloves with Protein Claim (50 MG or Less)Ssc Surat Thani · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970794	Latex Patient Examination (Powderfree Glove)	Siam Sempermed Corp., Ltd.	1997	—
0 (this device)	K100907	Non-Sterile, Powder Free Latex Examination Gloves and Protein Claim (50…	Siam Sempermed Corp., Ltd.	2010	—
+1	K111133	Non-Sterile, Powder Free Latex Examination Gloves with Protein Claim (50 MG or…	Ssc Surat Thani	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K100907, 1997–2011Source: 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
*	K970794	Latex Patient Examination (Powderfree Glove) Summary page 2 …expressed in the tabulated comparison as below. Technical comparison of specific elements is attached in the main submission. FDA file refcrence number 510k number : K970794 Attachments inside notification submission file REFER TO APPENDIX 1 TECHNOLOGICAL CHARACTERISTICS Comparison result REFER TO…	Siam Sempermed Corp., Ltd.	1997	—

Also cleared against K970794: 4 other devices →

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
K111133	Non-Sterile, Powder Free Latex Examination Gloves with Protein Claim (50 MG or Less)	Ssc Surat Thani	2011	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, K111133 (Ssc Surat Thani, 2011) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K970794.

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. 2010, this device’s year, is highlighted.

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?

A patient examination glove is a disposable device intended for

medical purposes that is worn on the examiner's hand or finger

to prevent contamination between patient and examiner.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K100907 · printed Nov 4, 2026

Cite this page

510(k) Report. “K100907: Non-Sterile, Powder Free Latex Examination Gloves and Protein Claim (50 Micrograms or Less) Model: White: X-Small, Small.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100907

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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