510(k) Report

FDA applicant

Hongye Plastic Products Co., Ltd.

Chino, CA2 decisions2006–20130 recalls

FDA records 2 decisions for Hongye Plastic Products Co., Ltd. (Chino, CA) from 2006 to 2013: 2 510(k) clearances. All are in product code LZA (Polymer 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 Hongye Plastic Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hongye Plastic Products Co., Ltd. by year, 2007–2026Sources: 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 Glove2decisions

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?

  • K122408Powder Free Nitrile Examination Gloves (Black, White, Green)Hongye Plastic Products Co., Ltd. · 2013
  • K060147Powder Free Nitrile Examination Gloves, BlueHongye Plastic Products Co., Ltd. · 2006

All 2 as Hongye Plastic Products Co., Ltd. →