510(k) Report

FDA applicant

Shanghai Gangkai Purifying Products Co., Ltd.

Vero Beach, FL1 decision2006–20060 recalls

FDA records 1 decision for Shanghai Gangkai Purifying Products Co., Ltd. (Vero Beach, FL) in 2006: 1 510(k) clearance. All are in product code MSH (Respirator, Surgical). 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 and plastic surgery panel, where it files most

How often FDA has decided Shanghai Gangkai Purifying Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shanghai Gangkai Purifying Products Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shanghai Gangkai Purifying Products 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?

  • MSHRespirator, Surgical1decision

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?

  • K063334Shanghai Ganghai Model Giko 1400Shanghai Gangkai Purifying Products Co., Ltd. · 2006

The one decision as Shanghai Gangkai Purifying Products Co., Ltd. →