510(k) Report

FDA applicant

Hebei Manful Import & Export Co., Ltd.

Jinzhou City, Hebei, CN2 decisions2005–20050 recalls

FDA records 2 decisions for Hebei Manful Import & Export Co., Ltd. (Jinzhou City, Hebei, CN) in 2005: 2 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). 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 Hebei Manful Import & Export Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hebei Manful Import & Export Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hebei Manful Import & Export 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?

  • LYZVinyl Patient Examination Glove2decisions

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?

  • K051154Powdered Vinyl Patient Examination Gloves, White (Non-Colored)Hebei Manful Import & Export Co., Ltd. · 2005
  • K051153Powder Free Vinyl Patient Examination Gloves, White (Non-Colored)Hebei Manful Import & Export Co., Ltd. · 2005

All 2 as Hebei Manful Import & Export Co., Ltd. →