510(k) Report

FDA applicant

Zhejiang Gongdong Medical Plastic Factory

Huangyan, Taizhou, Zhejiang, CN2 decisions2005–20080 recalls

FDA records 2 decisions for Zhejiang Gongdong Medical Plastic Factory (Huangyan, Taizhou, Zhejiang, CN) from 2005 to 2008: 2 510(k) clearances. Most are in product codes HIB (Speculum, Vaginal, Nonmetal) and MMK (Container, Sharps). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Zhejiang Gongdong Medical Plastic Factory’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zhejiang Gongdong Medical Plastic 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?

  • HIBSpeculum, Vaginal, Nonmetal1decision
  • MMKContainer, Sharps1decision

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K050887Gongdong Disposable Vaginal SpeculumZhejiang Gongdong Medical Plastic Factory · 20052cite it
  • K082042Gongdong Disposable Sharp ContainerZhejiang Gongdong Medical Plastic Factory · 20081cites it

What has FDA decided for it lately?

  • K082042Gongdong Disposable Sharp ContainerZhejiang Gongdong Medical Plastic Factory · 2008
  • K050887Gongdong Disposable Vaginal SpeculumZhejiang Gongdong Medical Plastic Factory · 2005

All 2 as Zhejiang Gongdong Medical Plastic Factory →