510(k) Report

FDA applicant

Siam Sempermed Corp., Ltd.

Clearwater, FL37 decisions1989–20150 recalls

FDA records 37 decisions for Siam Sempermed Corp., Ltd. (Clearwater, FL) from 1989 to 2015: 37 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Its devices cite 17 predicates, 15 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Siam Sempermed Corp., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 12008: 32009: 32010: 12012: 22015: 1
2007high 3 (2008) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Siam Sempermed Corp., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Siam Sempermed Corp., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LYYLatex Patient Examination Glove19decisions
  • LZAPolymer Patient Examination Glove17decisions
  • OPEUnnamed device1decision

Whose devices does it build on?

Its devices cite 17 predicates; 15 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 15 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K970794Latex Patient Examination (Powderfree Glove)Siam Sempermed Corp., Ltd. · 19975cite it
  • K083755Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color, Polymer Coated, Texted with…Siam Sempermed Corp., Ltd. · 20094cite it
  • K080520Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with Chemotherapy ClaimSiam Sempermed Corp., Ltd. · 20083cite it
  • K060753Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating, Model Blue: All Sizes (XS-XL)Siam Sempermed Corp., Ltd. · 20062cite it
  • K000323Nitrile Patient Examination Glove (Blue Color) Powder Free, Non SterileSiam Sempermed Corp., Ltd. · 20001cites it
  • K024121Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating, Aloe, Vitamin E and Protein ClaimSiam Sempermed Corp., Ltd. · 20021cites it

What has FDA decided for it lately?

  • K142685Nitrile Examination Gloves with Aloe & Vitamin E, Powder- FreeSiam Sempermed Corp., Ltd. · 2015
  • K121549Non-Sterile, Powder-Free Nitrile Examination Glove, BlueSiam Sempermed Corp., Ltd. · 2012
  • K122363Non-Sterile, Powder Free Nitrile Examination Gloves, BlueSiam Sempermed Corp., Ltd. · 2012
  • K100907Non-Sterile, Powder Free Latex Examination Gloves and Protein Claim (50 Micrograms or Less) Model: White…Siam Sempermed Corp., Ltd. · 2010
  • K082957Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer Coated, Tested with Chemotherapy DrugsSiam Sempermed Corp., Ltd. · 2009
  • K083755Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color, Polymer Coated, Texted with…Siam Sempermed Corp., Ltd. · 2009
  • K081911Non-Sterile, Powdered Nitrile Examination Glove, BlueSiam Sempermed Corp., Ltd. · 2009
  • K081910Non-Sterile, Powdered Latex Examination GloveSiam Sempermed Corp., Ltd. · 2008

All 37 as Siam Sempermed Corp., Ltd. →

Other applicant names beginning “Siam”

FDA records each applicant name separately; these may or may not be the same firm.

Siam Ntd Corporation Co., Ltd. 1