510(k) Report

FDA applicant

Spi Gloves Sdn. Bhd.

Ipoh 30450, MY7 decisions2005–20050 recalls

FDA records 7 decisions for Spi Gloves Sdn. Bhd. (Ipoh 30450, MY) in 2005: 7 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). 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 Spi Gloves Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spi Gloves Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Spi Gloves Sdn. Bhd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LYYLatex Patient Examination Glove4decisions
  • LZAPolymer Patient Examination Glove3decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K050527Powdered Latex Examination Gloves with Protein Labeling Claim (Contains 200 Micrograms or Less of Total…Spi Gloves Sdn. Bhd. · 20051cites it

What has FDA decided for it lately?

  • K050526Polymer Coated Online Chlorinated Powder Free Examination Gloves with Protein Labeling Claim (Contains 50…Spi Gloves Sdn. Bhd. · 2005
  • K050528Powder Free Nitrile Examination Gloves (Blue,White,Violet,Pink,Green,Black)Spi Gloves Sdn. Bhd. · 2005
  • K050532Chlorinated Powder Free Latex Examination Gloves with Protein Labeling Claim (Contains 50 Micrograms or Less…Spi Gloves Sdn. Bhd. · 2005
  • K050531Powdered Nitrile Examination Gloves (Blue,White)Spi Gloves Sdn. Bhd. · 2005
  • K050527Powdered Latex Examination Gloves with Protein Labeling Claim (Contains 200 Micrograms or Less of Total…Spi Gloves Sdn. Bhd. · 2005
  • K050529Polymer Coated Powder Free Latex Examination Gloves with Protein Labeling Claim (Contains 50 Micrograms or…Spi Gloves Sdn. Bhd. · 2005
  • K050530Polymer Coated Powder Free Nitrile Examination Gloves (Blue,White,Violet, Pink,Green)Spi Gloves Sdn. Bhd. · 2005

All 7 as Spi Gloves Sdn. Bhd. →