510(k) Report

FDA applicant

Jiangxi Zhonghong Pulin Medical Products Co., Ltd.

Jiu Jiang, CN2 decisions2018–20210 recalls

FDA records 2 decisions for Jiangxi Zhonghong Pulin Medical Products Co., Ltd. (Jiu Jiang, CN) from 2018 to 2021: 2 510(k) clearances. Most are in product codes LYZ (Vinyl Patient Examination Glove) and LZA (Polymer 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 Jiangxi Zhonghong Pulin Medical Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2018: 12021: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Jiangxi Zhonghong Pulin Medical Products Co., Ltd. by year, 2018–2026Sources: 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 Glove1decision
  • LZAPolymer Patient Examination Glove1decision

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?

  • K210723Nitrile Patient Examination GloveJiangxi Zhonghong Pulin Medical Products Co., Ltd. · 2021
  • K182117Vinyl Patient Examination GlovesJiangxi Zhonghong Pulin Medical Products Co., Ltd. · 2018

All 2 as Jiangxi Zhonghong Pulin Medical Products Co., Ltd. →