510(k) Report

FDA applicant

Yunnan Huazhiyuan Medical Technology Co., Ltd.

Honghe Hani And Yi Autonomous Prefecture, CN4 decisions2021–20210 recalls

FDA records 4 decisions for Yunnan Huazhiyuan Medical Technology Co., Ltd. (Honghe Hani And Yi Autonomous Prefecture, CN) in 2021: 4 510(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 87 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 4 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 Yunnan Huazhiyuan Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2021

2021: 4
2021high 4 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Yunnan Huazhiyuan Medical Technology Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Yunnan Huazhiyuan Medical Technology…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LZAPolymer Patient Examination Glove2decisions
  • LYZVinyl Patient Examination Glove2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 87 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 101 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K210799Powder Free Vinyl Patient Examination GlovesYunnan Huazhiyuan Medical Technology Co., Ltd. · 20211cites it

What has FDA decided for it lately?

  • K213051Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)Yunnan Huazhiyuan Medical Technology Co., Ltd. · 2021
  • K212002Synthetic Vinyl Examination GlovesYunnan Huazhiyuan Medical Technology Co., Ltd. · 2021
  • K210686Nitrile Patient Examination GloveYunnan Huazhiyuan Medical Technology Co., Ltd. · 2021
  • K210799Powder Free Vinyl Patient Examination GlovesYunnan Huazhiyuan Medical Technology Co., Ltd. · 2021

All 4 as Yunnan Huazhiyuan Medical Technology Co., Ltd. →