510(k) Report

FDA applicant

Shandong Hongxin Chemicals Co., Ltd.

Zibo, CN2 decisions2012–20210 recalls

FDA records 2 decisions for Shandong Hongxin Chemicals Co., Ltd. (Zibo, CN) from 2012 to 2021: 2 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). 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 hospital panel, where it files most

How often FDA has decided Shandong Hongxin Chemicals Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2012: 12021: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Shandong Hongxin Chemicals Co., Ltd. by year, 2012–2026Sources: 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 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K212488Synthetic Nitrile Examination GlovesShandong Hongxin Chemicals Co., Ltd. · 2021
  • K122828Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Shandong Hongxin Chemicals Co., Ltd. · 2012

All 2 as Shandong Hongxin Chemicals Co., Ltd. →