510(k) Report

FDA applicant

Shanghai Latex Factory

Houston, TX3 decisions1989–20050 recalls

FDA records 3 decisions for Shanghai Latex Factory (Houston, TX) from 1989 to 2005: 3 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and HIS (Condom). Its devices cite 1 predicate, 0 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 Shanghai Latex Factory’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shanghai Latex Factory since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shanghai Latex Factory 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 Glove2decisions
  • HISCondom1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K050360Tulip CondomShanghai Latex Factory · 2005
  • K892138Patient Examination Gloves (Latex)Shanghai Latex Factory · 1989
  • K893280Profect Examination GlovesShanghai Latex Factory · 1989

All 3 as Shanghai Latex Factory →