510(k) Report

FDA applicant

Shanghai Jianzhong Medical Packaging Co., Ltd.

Shanghai, CN3 decisions2007–20250 recalls

FDA records 3 decisions for Shanghai Jianzhong Medical Packaging Co., Ltd. (Shanghai, CN) from 2007 to 2025: 3 510(k) clearances. Most are in product codes FRG (Wrap, Sterilization) and FXX (Mask, Surgical). Its devices cite 2 predicates, 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 Jianzhong Medical Packaging Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 12021: 12025: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shanghai Jianzhong Medical Packaging Co., Ltd. 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?

  • FRGWrap, Sterilization2decisions
  • FXXMask, Surgical1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K242898Sterilization Pouches and ReelsShanghai Jianzhong Medical Packaging Co., Ltd. · 2025
  • K202341Disposable Surgical MaskShanghai Jianzhong Medical Packaging Co., Ltd. · 2021
  • K071886Self Seal Sterilization PouchShanghai Jianzhong Medical Packaging Co., Ltd. · 2007

All 3 as Shanghai Jianzhong Medical Packaging Co., Ltd. →