510(k) Report

FDA applicant

Hebei Hongtai Plastic Products Co., Ltd.

Beijing, CN3 decisions2010–20170 recalls

FDA records 3 decisions for Hebei Hongtai Plastic Products Co., Ltd. (Beijing, CN) from 2010 to 2017: 3 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Hebei Hongtai Plastic Products Company Limited”.

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 Hebei Hongtai Plastic Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2010: 22017: 1
2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Hebei Hongtai Plastic Products Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hebei Hongtai Plastic Products Co., Ltd.’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?

  • LYZVinyl Patient Examination Glove3decisions

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 17 times; 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.

  • K163168Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)Hebei Hongtai Plastic Products Company Limited · 201717cite it

What has FDA decided for it lately?

  • K163168Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)Hebei Hongtai Plastic Products Company Limited · 2017
  • K102817Powder-Free Vinyl Patient Examination GlovesHebei Hongtai Plastic Products Co., Ltd. · 2010
  • K102819Powder-Free Vinyl Patient Examination GlovesHebei Hongtai Plastic Products Co., Ltd. · 2010

All 2 as Hebei Hongtai Plastic Products Co., Ltd. →The one decision as Hebei Hongtai Plastic Products Company Limited →