510(k) Report

FDA applicant

Khai Hoan Joint Stock Company

Binh Duong Province, VN2 decisions2010–20120 recalls

FDA records 2 decisions for Khai Hoan Joint Stock Company (Binh Duong Province, VN) from 2010 to 2012: 2 510(k) clearances. All are in product code LYY (Latex 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 Khai Hoan Joint Stock Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010: 12012: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Khai Hoan Joint Stock Company by year, 2010–2026Sources: 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

What has FDA decided for it lately?

  • K113685Powder Free Latex Examination GlovesKhai Hoan Joint Stock Company · 2012
  • K092681Powdered Latex Examination Gloves, Non-SterileKhai Hoan Joint Stock Company · 2010

All 2 as Khai Hoan Joint Stock Company →