510(k) Report

FDA applicant

Jiangsu Dihong Industry and Trade Co., Ltd.

Shuyang, CN2 decisions2021–20210 recalls

FDA records 2 decisions for Jiangsu Dihong Industry and Trade Co., Ltd. (Shuyang, CN) in 2021: 2 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and 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 Jiangsu Dihong Industry and Trade Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2021: 2
2021high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Jiangsu Dihong Industry and Trade Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jiangsu Dihong Industry and Trade Co.…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LZAPolymer Patient Examination Glove1decision
  • LYZVinyl Patient Examination Glove1decision

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?

  • K211904Vinyl GloveJiangsu Dihong Industry and Trade Co., Ltd. · 2021
  • K211252Nitrile GloveJiangsu Dihong Industry and Trade Co., Ltd. · 2021

All 2 as Jiangsu Dihong Industry and Trade Co., Ltd. →