510(k) Report

FDA applicant

Shandong Hengya Packaging Printing Co.,Ltd

Weifang City, CN1 decision2019–20190 recalls

FDA records 1 decision for Shandong Hengya Packaging Printing Co.,Ltd (Weifang City, CN) in 2019: 1 510(k) clearance. All are in product code LZA (Polymer 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 Shandong Hengya Packaging Printing Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Shandong Hengya Packaging Printing Co.,Ltd by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LZAPolymer Patient Examination Glove1decision

What has FDA decided for it lately?

  • K182640Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)Shandong Hengya Packaging Printing Co.,Ltd · 2019

The one decision as Shandong Hengya Packaging Printing Co.,Ltd →