510(k) Report

FDA applicant

Teh Loong Corp.

Chicago, IL3 decisions2005–20050 recalls

FDA records 3 decisions for Teh Loong Corp. (Chicago, IL) in 2005: 3 510(k) clearances. All are in product code LYZ (Vinyl 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 Teh Loong Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Teh Loong Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • LYZVinyl Patient Examination Glove3decisions

What has FDA decided for it lately?

  • K052635Teh Loong Powdered Synthetic Vinyl Patient Examination Gloves, YellowTeh Loong Corp. · 2005
  • K052636Teh Loong Powder Free Synthetic Vinyl Patient Examination Gloves, YellowTeh Loong Corp. · 2005
  • K052634Teh Loong Powdered Synthetic Vinyl Patient Examination Gloves, WhiteTeh Loong Corp. · 2005

All 3 as Teh Loong Corp. →