510(k) Report

FDA applicant

Zhonghong Pulin Medical Products Co., Ltd.

Tangshan, CN5 decisions2016–20230 recalls

FDA records 5 decisions for Zhonghong Pulin Medical Products Co., Ltd. (Tangshan, CN) from 2016 to 2023: 5 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYZ (Vinyl Patient Examination Glove). Since 2016 its 510(k)s took a median of 170 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Zhonghong Pulin Medical Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2016: 12017: 12021: 12023: 2
2016high 2 (2023) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Zhonghong Pulin Medical Products Co., Ltd. by year, 2016–2026Sources: 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 Glove4decisions
  • LYZVinyl Patient Examination Glove1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 170 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 92 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K231029Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And FentanylZhonghong Pulin Medical Products Co., Ltd. · 2023
  • K230662Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select…Zhonghong Pulin Medical Products Co., Ltd. · 2023
  • K210460NitriTec Vinyl Glove Powder Free BlueZhonghong Pulin Medical Products Co., Ltd. · 2021
  • K171873Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy…Zhonghong Pulin Medical Products Co., Ltd. · 2017
  • K152712Nitrile Powder Free Patient Examination Gloves, Blue ColorZhonghong Pulin Medical Products Co., Ltd. · 2016

All 5 as Zhonghong Pulin Medical Products Co., Ltd. →